LVIS EVO Stent-Assisted Coiling for Intracranial Aneurysms: Results of Long-Term Follow-Up

LVIS EVO Stent-Assisted Coiling for Intracranial Aneurysms: Results of Long-Term Follow-Up | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article LVIS EVO Stent-Assisted Coiling for Intracranial Aneurysms: Results of Long-Term Follow-Up Felix Wei, Maxime Geismar, Erwah Kalsoum, Thanh Nguyen, Raghid Kikano, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7507868/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 18 Nov, 2025 Read the published version in Neuroradiology → Version 1 posted You are reading this latest preprint version Abstract Background The Low-profile visualized Intraluminal Support EVO (LVIS EVO) is a next-generation braided stent characterized by enhanced visibility and resheathability, and designed for stent-assisted coil embolization of intracranial aneurysms. Despite growing adoption, real-world data on its efficacy and safety remain limited. Objective This study aims to evaluate the safety and efficacy of the LVIS EVO stent in consecutive patients undergoing treatment for brain aneurysms. Methods We retrospectively analyzed all patients who underwent treatment of unruptured intracranial aneurysms with the LVIS EVO stent in a single tertiary center between January 2021 and January 2024. Baseline demographics, imaging and procedural characteristics, clinical outcomes, and clinical and radiological follow-up data were collected. The primary endpoints were successful deployment and complete aneurysm occlusion at follow-up as defined by the Raymond-Roy Occlusion Classification. Secondary endpoints included complication rate, modified Rankin Scale (mRS) at last clinical follow-up, and incidence of in-stent stenosis on last follow-up imaging. Results Thirty-four patients (64.7% women; median age: 52 years) were treated for 34 saccular aneurysms. Most of the aneurysms were previously ruptured, and recanalized after initial treatment (20/34, 58.8%). They were located at the middle cerebral artery (15/34, 44.12%) or internal carotid artery terminus (8/34, 23.5%). Median aneurysm neck size was 3.3 mm, with an aspect ratio of 1.2 and a dome-to-neck ratio of 1.3. Stent deployment was successful in 100% of cases. Immediate complete occlusion (RROCs I) was achieved in 82.4% of aneurysms. At a median radiological follow-up of 24 months, 91.2% of aneurysms remained completely occluded, and 97.1% were adequately occluded (RROC I–II). Two intraprocedural cases (5.9%) of in-stent thrombosis occurred and were managed successfully. One post-procedural symptomatic ischemic event occurred, but the patient was asymptomatic at the last clinical follow-up. There were no hemorrhagic or permanent ischemic complications. Asymptomatic in-stent stenosis occurred in 2 patients (5.9%). Clinical outcome was favorable (mRS ≤ 2) in 100% of cases at last follow-up. Conclusion The LVIS EVO stent demonstrates excellent technical success and sustained aneurysm occlusion with a low complication rate. These results support its safety and efficacy in the treatment of intracranial aneurysms, including previously ruptured lesions and anatomically complex locations. Figures Figure 1 Figure 2 Introduction Endovascular treatment of intracranial aneurysms has undergone remarkable advances over the last two decades, evolving from simple coiling techniques to the integration of stent assistance and flow diversion, which allow the treatment of more complex aneurysms. ( 1 – 3 ) Stent-assisted coiling (SAC) has expanded the scope of the endovascular treatment of intracranial aneurysms. ( 5 ) Particularly, the development of low-profile braided stents in wide-neck aneurysms enhanced coil retention and aneurysm occlusion durability. ( 6 ) The Low-profile Visualized Intraluminal Support (LVIS) EVO (Microvention, Tustin, California) is the latest generation of the LVIS family. It is a self-expanding, braided nitinol stent incorporating drawn filled tube (DFT) technology, in which each wire combines a platinum core and a nitinol outer layer, resulting in enhanced radiopacity under fluoroscopy. Its resheathability and flared ends, shorter than those of the LVIS Jr, allow better navigability and more controlled deployment in complex or distal anatomies. Compatible with 0.017-inch microcatheters, the LVIS EVO is suitable for use in small-caliber vessels. While some studies have explored the performance of the LVIS EVO in unruptured aneurysms, particularly in the context of early feasibility in the United States and Europe, few have examined its use in a broader clinical context, including retreatments and previously ruptured lesions. ( 7 – 10 ) Furthermore, the impact of systematic dual antiplatelet therapy with ticagrelor, in contrast to clopidogrel, is yet to be fully understood in relation to the device's thromboembolic profile. This study aims to address these gaps by reporting on a consecutive series of aneurysms treated with the LVIS EVO at a single tertiary neurointerventional center. Materials and Methods Study Design and Ethical Approval This was a retrospective observational study conducted at a high-volume academic center. The protocol was approved by the institutional ethics committee (Le Collège des Enseignants en Radiologie de France, IRB CRM-2506-472). The database was prospectively maintained and retrospectively analyzed. The need to obtain patient informed consent was waived because of the retrospective study design. The study was performed under the guidelines outlined by the Declaration of Helsinki and followed the STROBE checklist. Inclusion and Exclusion Criteria Patients aged 18 years or older who underwent elective endovascular treatment with the LVIS EVO stent between January 2021 and January 2024 were included. Only saccular aneurysms were considered. Aneurysms treated in the acute phase of rupture or with a non-saccular morphology (fusiform, blister-like, or dissecting) were excluded. Patients without at least 12 months of clinical and radiological follow-up were also excluded. Peri-procedural Management All patients received dual antiplatelet therapy with aspirin 75 mg/day and ticagrelor 180 mg/day one day before the procedure. Platelet function testing was not routinely performed due to protocol standardization. All procedures were performed under general anesthesia. Endovascular Procedures and Antiplatelet Protocol Treatment decisions were reached through a multidisciplinary team consensus. The procedure was performed via triaxial or coaxial system, through the femoral or radial approach. The EVO stent was deployed using standard techniques through either the Headway 17 microcatheter (Microvention, Tustin, California). Aneurysm coiling was conducted using the jailing technique. Intravenous unfractionated heparin (50 UI/kg) was administered at the start of the procedure, followed by hourly boluses of 1,000 IU. In cases where thrombus formation occurred, intra-arterial tirofiban (dosage administered as per protocol) was administered to achieve thrombolysis. Post-procedure, patients were maintained on dual antiplatelet therapy for a minimum of three months. Long-term management consisted of aspirin monotherapy. Data Collection and Follow-up Baseline clinical data, aneurysm characteristics, and procedural variables were systematically recorded. Technical success was defined as successful deployment of the stent across the aneurysm neck. Complications were classified as intraoperative and post-procedural. Radiologic outcomes were assessed using the Raymond-Roy occlusion classification (RROC), in which class I is defined as complete occlusion; class II, as a neck remnant; and class III, as a sac remnant. Radiological follow-up included MRA at 6 and 12 months, followed by MRA annually. Clinical evaluation was performed at discharge, 6 months, and 1 year using the modified Rankin Scale (mRS). In-stent stenosis was defined as ≥ 50% narrowing at follow-up imaging. Statistical Analysis Quantitative variables were described using medians and interquartile ranges (IQR); categorical variables were reported as counts and percentages. No imputation was performed. Given the descriptive aim, no inferential statistics were applied. Results Demographic and Clinical Characteristics Thirty-four patients (64.7% women; median age: 52 years, IQR 43–58) were treated for 34 saccular aneurysms. Hypertension was present in 13 (38.2%), hyperlipidemia in 5 (14.7%), and diabetes in 2 (5.9%) of our patients. Active smoking was reported in 4 (17.6%) patients, with an additional 6 (17.7%) being former smokers. A previous ischemic stroke was reported in 3 patients (8.8%). All patients presented a baseline mRS ≤ 2. Aneurysm Features All aneurysms were saccular. Most were located at the MCA bifurcation (15, 44.1%) and ICA terminus (8, 23.5%), followed by anterior communicating artery (AComA) (7, 20.6%) and basilar apex (4, 11.8%). More than half (20, 58.8%) had previously ruptured. Median aneurysm size was 4.5 mm (IQR 3.63–6.25) and median neck size was 3.3 mm (IQR 2.7–4.6), with a median aspect ratio of 1.2 (1.00-1.58) and dome-to-neck ratio of 1.3 (IQR 1.01–1.62). Branch incorporation in the aneurysmal sac was present in 3 aneurysms (8.8%). Procedural Data and antiplatelet therapy All procedures were performed under general anesthesia. A triaxial system was used in 26 patients (74.3%). Radial access was used in 25.7% of cases. A single LVIS EVO stent was deployed in 33/35 cases (94.3%) and two stents in 2 cases (5.9%), with successful delivery and no need for adjunctive stents or rescue maneuvers. Coil embolization was performed in all cases using a jailed microcatheter technique. No post-deployment balloon angioplasty was performed. The median procedure duration was 172 minutes (IQR 160–204). Intra-procedural heparinization was performed according to protocol, with a target activated clotting time (ACT) of 250–300 seconds. All patients received dual antiplatelet therapy for a minimum of 3 months post-procedure, 28/34 patients (82.4%) for 3 months and 6/34 (17.6%) for 6 months. Angiographic Outcomes Immediate RROC I occlusion was achieved in 28/34 cases (82.4%). (Fig. 1 ) At a median follow-up of 24 months, complete occlusion (RROC I) was noted in 31/34 aneurysms (91.2%). Neck remnants (RROC II) were observed in 2 (5.9%). We recorded two cases of moderate (< 50%) in-stent stenosis (5.9%) at last follow-up. (Fig. 2 ) No aneurysm required retreatment or presented with delayed rupture. Complications and Clinical Outcomes Two intraprocedural cases of in-stent thrombosis (5.7%) were recorded (managed with an i.v. bolus of tirofiban, with complete resolution of the thrombus). One post-procedural symptomatic ischemic complication was noted, but it was asymptomatic at the last clinical follow-up. No hemorrhagic event occurred. At last clinical follow-up, all patients were functionally independent (mRS ≤ 2). Discussion Our findings confirm the safety and the efficacy of the LVIS EVO stent for the endovascular treatment of intracranial saccular aneurysms with a 100% technical success rate and 97.1% of adequate occlusion (RROC I + II) at 2 years. Our results demonstrate superior occlusion rates compared to a multicenter feasibility study by Kayan et al., which reported 33% immediate RROC I occlusion in unruptured aneurysms. ( 8 ) The high RROC I rates in our study may be attributed to the systematic use of the jailed microcatheter technique which facilitated high coil packing density and potentially enhanced the aneurysmal sac thrombogenesis. Additionally, the stent's metal coverage (approximately 28%) and densely braided design likely contributed to flow modification, further promoting intra-aneurysmal thrombosis, similar to that seen with flow-diverting devices. The safety profile in our study is also notable, with only two transient thromboembolic events (5.7%), both of which were successfully managed with no permanent disability. These complication rates are favorable compared to previous studies involving low-profile stents. The consistent use of ticagrelor as part of the dual antiplatelet regimen may have played a key role in minimizing periprocedural thromboembolic complications and supporting safe stent endothelialization in our series. Ticagrelor is a direct-acting, reversible P2Y12 inhibitor, providing more predictable and potent platelet inhibition compared to clopidogrel, which is subject to variable metabolic activation and resistance. Although systematic platelet function testing was not conducted, the exclusive use of ticagrelor likely contributed to a more consistent antiplatelet effect, reducing interindividual variability compared to clopidogrel-based regimens.( 12 ) Furthermore, several recent studies have suggested that ticagrelor-based regimens may be associated with lower rates of high on-treatment platelet reactivity (HTPR) ( 9 ) and could have contributed to the low rates of in-stent stenosis (5.9%) caused by intimal hyperplasia in our series. Our study expands the current body of knowledge by including a substantial proportion of previously coiled and recanalized aneurysms (58.8%) located in anatomically complex regions such as the MCA and ICA terminus. These aneurysms are often underrepresented. Managing these lesions, often underrepresented in major studies, is especially challenging due to their history of rupture, elevated risk of rebleeding, and frequently complex morphology.11) An additional strength of our series is the long median radiological and clinical follow-up (24 months), exceeding most previous LVIS EVO reports. This duration allows for more robust evaluation of the device’s durability and supports the use of complete occlusion as a surrogate for long-term protection from aneurysm recurrence or rupture. From a technical perspective, the device’s resheathability and high radiopacity—thanks to DFT wires—were especially valuable in complex cases involving incorporated branches. These properties permitted precise stent positioning, particularly critical when the aneurysm neck was adjacent to important perforators or bifurcations. Furthermore, the anatomical versatility of the LVIS EVO, including its deployment through a 0.017-inch microcatheter and its favorable mechanical behavior in tortuous and distal vascular segments, makes it an attractive option for neurointerventionalists. Our experience supports its use across various intracranial locations, including bifurcation points and vessels with critical perforating branches. It is also notable that no cases in our series required adjunctive devices such as balloons. This underscores the reliability of the EVO’s deployment characteristics and its ability to conform adequately to the vessel wall without adjunctive maneuvers. While our results are promising, prospective comparative studies are necessary to delineate the relative benefits of the EVO stent versus alternative stents such as Neuroform Atlas or flow diverter stents, particularly in distal aneurysms. Conclusion The LVIS EVO stent demonstrates excellent technical success and sustained aneurysm occlusion with a low complication rate. These results support its safety and efficacy in the treatment of intracranial aneurysms, including previously ruptured lesions and anatomically complex locations. Declarations Conflicts of Interest None declared. No funding was received for this study Human Ethics and Consent to Participate declarations: not applicable Author Contribution L.S. ,F.W., M.A.,A.A.D. and M.G. conceived of the presented idea. L.S. , E.K.,R.K. and T.N. performed the research in the literature. All the authors gave substantial contribution for acquisition of data. L.S. and M.G. performed the analysis. L.S.,F.W.,M.G. and M.A. wrote the manuscript. All the authors reviewed the manuscript and made corrections/comments and substantial contribution to the final version of the manuscript. L.S., M.A. and E.K. supervided the finding and the study. 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PMID: 34740986; PMCID: PMC9606530 Donnard B, Bala F, Boulouis G, Herbreteau D, Ifergan H, Barrot V, Giubbolini F, Bankole NDA, Hoche C, Bibi R, Janot K (2025) Safety of Ticagrelor Use in Elective Endovascular Treatment of Unruptured Intracranial Aneurysms. Neurosurgery. May 15. 10.1227/neu.0000000000003507 . Epub ahead of print. PMID: 40372047 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 18 Nov, 2025 Read the published version in Neuroradiology → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7507868","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":513765344,"identity":"64e1a669-445c-40ce-b94f-999f678f34ea","order_by":0,"name":"Felix Wei","email":"","orcid":"","institution":"Hôpitaux Universitaires Henri-Mondor","correspondingAuthor":false,"prefix":"","firstName":"Felix","middleName":"","lastName":"Wei","suffix":""},{"id":513765345,"identity":"d1727495-f440-45a9-a459-eb66c033aca6","order_by":1,"name":"Maxime Geismar","email":"","orcid":"","institution":"Hôpitaux Universitaires 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11:23:54","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7507868/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7507868/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s00234-025-03808-6","type":"published","date":"2025-11-18T15:57:02+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":91305241,"identity":"a519b594-0290-406f-9c1c-f383e528ef17","added_by":"auto","created_at":"2025-09-15 06:25:06","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":119501,"visible":true,"origin":"","legend":"\u003cp\u003e(A) Digital subtraction angiography (DSA) showing a recurrent, broad-necked aneurysm at the junction of the left A3 and A3 segments, initially treated with coiling after rupture.\u003cbr\u003e\n (B) Final DSA control after endovascular retreatment stent and coil embolization, showed the excellent visibility of the LVIS EVO.\u003c/p\u003e","description":"","filename":"Fig.1LVIS.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7507868/v1/d47a48050dfbd79b0ee91907.jpg"},{"id":91305258,"identity":"a6c9e11e-4fa7-49bc-9bc4-2f6934954777","added_by":"auto","created_at":"2025-09-15 06:25:08","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":129705,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eBasilar trunk aneurysm treated with braided stent-assisted coiling, complicated by proximal in-stent stenosis at 1-year follow-up.\u003c/strong\u003e\u003cbr\u003e\n(A) Native angiographic image obtained 1 year after treatment of a broad-necked basilar trunk aneurysm with LVIS EVO stent and dense coiling, showing complete occlusion of the aneurysm sac.\u003cbr\u003e\n(B) Corresponding digital subtraction angiography at 1 year demonstrates a proximal in-stent stenosis (green arrow) in the basilar artery, while aneurysm occlusion is maintained.\u003c/p\u003e","description":"","filename":"Fig.2LVIS.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7507868/v1/8926b5c53f1697cc2f2df8d5.jpg"},{"id":96650479,"identity":"45bcf701-4df2-48d1-badf-3583c2394150","added_by":"auto","created_at":"2025-11-24 16:12:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":898835,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7507868/v1/26db3069-0330-48b0-8f58-19043134c782.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"LVIS EVO Stent-Assisted Coiling for Intracranial Aneurysms: Results of Long-Term Follow-Up","fulltext":[{"header":"Introduction","content":"\u003cp\u003eEndovascular treatment of intracranial aneurysms has undergone remarkable advances over the last two decades, evolving from simple coiling techniques to the integration of stent assistance and flow diversion, which allow the treatment of more complex aneurysms. (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) Stent-assisted coiling (SAC) has expanded the scope of the endovascular treatment of intracranial aneurysms. (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) Particularly, the development of low-profile braided stents in wide-neck aneurysms enhanced coil retention and aneurysm occlusion durability. (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eThe Low-profile Visualized Intraluminal Support (LVIS) EVO (Microvention, Tustin, California) is the latest generation of the LVIS family. It is a self-expanding, braided nitinol stent incorporating drawn filled tube (DFT) technology, in which each wire combines a platinum core and a nitinol outer layer, resulting in enhanced radiopacity under fluoroscopy. Its resheathability and flared ends, shorter than those of the LVIS Jr, allow better navigability and more controlled deployment in complex or distal anatomies. Compatible with 0.017-inch microcatheters, the LVIS EVO is suitable for use in small-caliber vessels.\u003c/p\u003e\u003cp\u003eWhile some studies have explored the performance of the LVIS EVO in unruptured aneurysms, particularly in the context of early feasibility in the United States and Europe, few have examined its use in a broader clinical context, including retreatments and previously ruptured lesions. (\u003cspan additionalcitationids=\"CR8 CR9\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) Furthermore, the impact of systematic dual antiplatelet therapy with ticagrelor, in contrast to clopidogrel, is yet to be fully understood in relation to the device's thromboembolic profile. This study aims to address these gaps by reporting on a consecutive series of aneurysms treated with the LVIS EVO at a single tertiary neurointerventional center.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy Design and Ethical Approval\u003c/h2\u003e\u003cp\u003eThis was a retrospective observational study conducted at a high-volume academic center. The protocol was approved by the institutional ethics committee (Le Coll\u0026egrave;ge des Enseignants en Radiologie de France, IRB CRM-2506-472). The database was prospectively maintained and retrospectively analyzed. The need to obtain patient informed consent was waived because of the retrospective study design. The study was performed under the guidelines outlined by the Declaration of Helsinki and followed the STROBE checklist.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eInclusion and Exclusion Criteria\u003c/h3\u003e\n\u003cp\u003ePatients aged 18 years or older who underwent elective endovascular treatment with the LVIS EVO stent between January 2021 and January 2024 were included. Only saccular aneurysms were considered. Aneurysms treated in the acute phase of rupture or with a non-saccular morphology (fusiform, blister-like, or dissecting) were excluded. Patients without at least 12 months of clinical and radiological follow-up were also excluded.\u003c/p\u003e\n\u003ch3\u003ePeri-procedural Management\u003c/h3\u003e\n\u003cp\u003eAll patients received dual antiplatelet therapy with aspirin 75 mg/day and ticagrelor 180 mg/day one day before the procedure. Platelet function testing was not routinely performed due to protocol standardization. All procedures were performed under general anesthesia.\u003c/p\u003e\n\u003ch3\u003eEndovascular Procedures and Antiplatelet Protocol\u003c/h3\u003e\n\u003cp\u003eTreatment decisions were reached through a multidisciplinary team consensus. The procedure was performed via triaxial or coaxial system, through the femoral or radial approach. The EVO stent was deployed using standard techniques through either the Headway 17 microcatheter (Microvention, Tustin, California). Aneurysm coiling was conducted using the jailing technique. Intravenous unfractionated heparin (50 UI/kg) was administered at the start of the procedure, followed by hourly boluses of 1,000 IU. In cases where thrombus formation occurred, intra-arterial tirofiban (dosage administered as per protocol) was administered to achieve thrombolysis.\u003c/p\u003e\u003cp\u003ePost-procedure, patients were maintained on dual antiplatelet therapy for a minimum of three months. Long-term management consisted of aspirin monotherapy.\u003c/p\u003e\n\u003ch3\u003eData Collection and Follow-up\u003c/h3\u003e\n\u003cp\u003eBaseline clinical data, aneurysm characteristics, and procedural variables were systematically recorded. Technical success was defined as successful deployment of the stent across the aneurysm neck. Complications were classified as intraoperative and post-procedural. Radiologic outcomes were assessed using the Raymond-Roy occlusion classification (RROC), in which class I is defined as complete occlusion; class II, as a neck remnant; and class III, as a sac remnant.\u003c/p\u003e\u003cp\u003e Radiological follow-up included MRA at 6 and 12 months, followed by MRA annually. Clinical evaluation was performed at discharge, 6 months, and 1 year using the modified Rankin Scale (mRS). In-stent stenosis was defined as \u0026ge;\u0026thinsp;50% narrowing at follow-up imaging.\u003c/p\u003e\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\u003ch2\u003eStatistical Analysis\u003c/h2\u003e\u003cp\u003eQuantitative variables were described using medians and interquartile ranges (IQR); categorical variables were reported as counts and percentages. No imputation was performed. Given the descriptive aim, no inferential statistics were applied.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003eDemographic and Clinical Characteristics\u003c/h2\u003e\u003cp\u003eThirty-four patients (64.7% women; median age: 52 years, IQR 43\u0026ndash;58) were treated for 34 saccular aneurysms. Hypertension was present in 13 (38.2%), hyperlipidemia in 5 (14.7%), and diabetes in 2 (5.9%) of our patients. Active smoking was reported in 4 (17.6%) patients, with an additional 6 (17.7%) being former smokers. A previous ischemic stroke was reported in 3 patients (8.8%). All patients presented a baseline mRS\u0026thinsp;\u0026le;\u0026thinsp;2.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eAneurysm Features\u003c/h2\u003e\u003cp\u003eAll aneurysms were saccular. Most were located at the MCA bifurcation (15, 44.1%) and ICA terminus (8, 23.5%), followed by anterior communicating artery (AComA) (7, 20.6%) and basilar apex (4, 11.8%). More than half (20, 58.8%) had previously ruptured. Median aneurysm size was 4.5 mm (IQR 3.63\u0026ndash;6.25) and median neck size was 3.3 mm (IQR 2.7\u0026ndash;4.6), with a median aspect ratio of 1.2 (1.00-1.58) and dome-to-neck ratio of 1.3 (IQR 1.01\u0026ndash;1.62). Branch incorporation in the aneurysmal sac was present in 3 aneurysms (8.8%).\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eProcedural Data and antiplatelet therapy\u003c/h2\u003e\u003cp\u003eAll procedures were performed under general anesthesia. A triaxial system was used in 26 patients (74.3%). Radial access was used in 25.7% of cases. A single LVIS EVO stent was deployed in 33/35 cases (94.3%) and two stents in 2 cases (5.9%), with successful delivery and no need for adjunctive stents or rescue maneuvers. Coil embolization was performed in all cases using a jailed microcatheter technique. No post-deployment balloon angioplasty was performed. The median procedure duration was 172 minutes (IQR 160\u0026ndash;204). Intra-procedural heparinization was performed according to protocol, with a target activated clotting time (ACT) of 250\u0026ndash;300 seconds. All patients received dual antiplatelet therapy for a minimum of 3 months post-procedure, 28/34 patients (82.4%) for 3 months and 6/34 (17.6%) for 6 months.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003eAngiographic Outcomes\u003c/h2\u003e\u003cp\u003eImmediate RROC I occlusion was achieved in 28/34 cases (82.4%). (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) At a median follow-up of 24 months, complete occlusion (RROC I) was noted in 31/34 aneurysms (91.2%). Neck remnants (RROC II) were observed in 2 (5.9%). We recorded two cases of moderate (\u0026lt;\u0026thinsp;50%) in-stent stenosis (5.9%) at last follow-up. (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e) No aneurysm required retreatment or presented with delayed rupture.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003eComplications and Clinical Outcomes\u003c/h2\u003e\u003cp\u003eTwo intraprocedural cases of in-stent thrombosis (5.7%) were recorded (managed with an i.v. bolus of tirofiban, with complete resolution of the thrombus). One post-procedural symptomatic ischemic complication was noted, but it was asymptomatic at the last clinical follow-up. No hemorrhagic event occurred. At last clinical follow-up, all patients were functionally independent (mRS\u0026thinsp;\u0026le;\u0026thinsp;2).\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur findings confirm the safety and the efficacy of the LVIS EVO stent for the endovascular treatment of intracranial saccular aneurysms with a 100% technical success rate and 97.1% of adequate occlusion (RROC I\u0026thinsp;+\u0026thinsp;II) at 2 years.\u003c/p\u003e\u003cp\u003eOur results demonstrate superior occlusion rates compared to a multicenter feasibility study by Kayan et al., which reported 33% immediate RROC I occlusion in unruptured aneurysms. (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) The high RROC I rates in our study may be attributed to the systematic use of the jailed microcatheter technique which facilitated high coil packing density and potentially enhanced the aneurysmal sac thrombogenesis. Additionally, the stent's metal coverage (approximately 28%) and densely braided design likely contributed to flow modification, further promoting intra-aneurysmal thrombosis, similar to that seen with flow-diverting devices.\u003c/p\u003e\u003cp\u003eThe safety profile in our study is also notable, with only two transient thromboembolic events (5.7%), both of which were successfully managed with no permanent disability. These complication rates are favorable compared to previous studies involving low-profile stents. The consistent use of ticagrelor as part of the dual antiplatelet regimen may have played a key role in minimizing periprocedural thromboembolic complications and supporting safe stent endothelialization in our series. Ticagrelor is a direct-acting, reversible P2Y12 inhibitor, providing more predictable and potent platelet inhibition compared to clopidogrel, which is subject to variable metabolic activation and resistance. Although systematic platelet function testing was not conducted, the exclusive use of ticagrelor likely contributed to a more consistent antiplatelet effect, reducing interindividual variability compared to clopidogrel-based regimens.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e) Furthermore, several recent studies have suggested that ticagrelor-based regimens may be associated with lower rates of high on-treatment platelet reactivity (HTPR) (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) and could have contributed to the low rates of in-stent stenosis (5.9%) caused by intimal hyperplasia in our series.\u003c/p\u003e\u003cp\u003eOur study expands the current body of knowledge by including a substantial proportion of previously coiled and recanalized aneurysms (58.8%) located in anatomically complex regions such as the MCA and ICA terminus. These aneurysms are often underrepresented. Managing these lesions, often underrepresented in major studies, is especially challenging due to their history of rupture, elevated risk of rebleeding, and frequently complex morphology.11)\u003c/p\u003e\u003cp\u003eAn additional strength of our series is the long median radiological and clinical follow-up (24 months), exceeding most previous LVIS EVO reports. This duration allows for more robust evaluation of the device\u0026rsquo;s durability and supports the use of complete occlusion as a surrogate for long-term protection from aneurysm recurrence or rupture.\u003c/p\u003e\u003cp\u003eFrom a technical perspective, the device\u0026rsquo;s resheathability and high radiopacity\u0026mdash;thanks to DFT wires\u0026mdash;were especially valuable in complex cases involving incorporated branches. These properties permitted precise stent positioning, particularly critical when the aneurysm neck was adjacent to important perforators or bifurcations. Furthermore, the anatomical versatility of the LVIS EVO, including its deployment through a 0.017-inch microcatheter and its favorable mechanical behavior in tortuous and distal vascular segments, makes it an attractive option for neurointerventionalists. Our experience supports its use across various intracranial locations, including bifurcation points and vessels with critical perforating branches. It is also notable that no cases in our series required adjunctive devices such as balloons. This underscores the reliability of the EVO\u0026rsquo;s deployment characteristics and its ability to conform adequately to the vessel wall without adjunctive maneuvers.\u003c/p\u003e\u003cp\u003eWhile our results are promising, prospective comparative studies are necessary to delineate the relative benefits of the EVO stent versus alternative stents such as Neuroform Atlas or flow diverter stents, particularly in distal aneurysms.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe LVIS EVO stent demonstrates excellent technical success and sustained aneurysm occlusion with a low complication rate. These results support its safety and efficacy in the treatment of intracranial aneurysms, including previously ruptured lesions and anatomically complex locations.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConflicts of Interest\u003c/strong\u003e None declared.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNo funding was received for this study\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHuman Ethics and Consent to Participate declarations:\u003c/strong\u003e not applicable\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eL.S. ,F.W., M.A.,A.A.D. and M.G. conceived of the presented idea. L.S. , E.K.,R.K. and T.N. performed the research in the literature. All the authors gave substantial contribution for acquisition of data. L.S. and M.G. performed the analysis. L.S.,F.W.,M.G. and M.A. wrote the manuscript. All the authors reviewed the manuscript and made corrections/comments and substantial contribution to the final version of the manuscript. L.S., M.A. and E.K. supervided the finding and the study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWang F, Chen X, Wang Y, Bai P, Wang HZ, Sun T, Yu HL (2016) Stent-assisted coiling and balloon-assisted coiling in the management of intracranial aneurysms: A systematic review \u0026amp; meta-analysis. J Neurol Sci 364:160\u0026ndash;166. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jns.2016.03.041\u003c/span\u003e\u003cspan address=\"10.1016/j.jns.2016.03.041\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003eEpub 2016 Mar 25. PMID: 27084238\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eK\u0026uuml;hn AL, Gounis MJ, Puri AS (2020) Introduction: History and Development of Flow Diverter Technology and Evolution. Neurosurgery 86:S3\u0026ndash;10\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e2 Dholakia R, Sadasivan C, Fiorella DJ et al (2017) Hemodynamics of Flow Diverters. J Biomech Eng ;139\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e3 Gory B, Berge J, Bonaf\u0026eacute; A et al (2019) Flow Diverters for Intracranial Aneurysms: The DIVERSION National Prospective Cohort Study. Stroke 50:3471\u0026ndash;3480\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eIosif C, Biondi A (2019) Braided stents and their impact in intracranial aneurysm treatment for distal locations: from flow diverters to low profile stents. Expert Rev Med Devices 16(3):237\u0026ndash;251 Epub 2019 Feb 6. PMID: 30686064\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChalouhi N, Jabbour P, Singhal S, Drueding R, Starke RM, Dalyai RT, Tjoumakaris S, Gonzalez LF, Dumont AS, Rosenwasser R, Randazzo CG (2013) Stent-assisted coiling of intracranial aneurysms: predictors of complications, recanalization, and outcome in 508 cases. Stroke 44(5):1348\u0026ndash;1353. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1161/STROKEAHA.111.000641\u003c/span\u003e\u003cspan address=\"10.1161/STROKEAHA.111.000641\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003eEpub 2013 Mar 19. PMID: 23512976\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eVollherbst DF, Berlis A, Maurer C et al (2021) Periprocedural safety and feasibility of the new LVIS EVO device for stent-assisted coiling of intracranial aneurysms: an observational multicenter study. AJNR Am J Neuroradiol 42:319\u0026ndash;326\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKayan Y, Delgado Almandoz JE, Copelan A, Matouk C, Chaudry MI, Altschul D, Essibayi MA, Goren O, Yim B, Tsappidi S, Zhang YJ, Hui FK, Samaniego EA, Gudino A, Siddiqui A, Jaikumar V, Puri AS, K\u0026uuml;hn AL, Singh J, Ringer A, Hanel RA, De Toledo OF, Dabus G, Gooch MR, Sizdahkhani S, Field NC, Paul AR (2025) Multicenter early United States feasibility study and periprocedural safety of LVIS EVO for the treatment of unruptured intracranial aneurysms. J Neurointerv Surg. ;17(4):405\u0026ndash;409. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/jnis-2024-021900\u003c/span\u003e\u003cspan address=\"10.1136/jnis-2024-021900\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. 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PMID: 39668485\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eVollherbst DF, Berlis A, Maurer C, Behrens L, Sirakov S, Sirakov A, Fischer S, Maus V, Holtmannsp\u0026ouml;tter M, Rautio R, Sinisalo M, Poncyljusz W, Janssen H, Wodarg F, Kabbasch C, Trenkler J, Herweh C, Bendszus M, M\u0026ouml;hlenbruch MA (2021) Periprocedural Safety and Feasibility of the New LVIS EVO Device for Stent-Assisted Coiling of Intracranial Aneurysms: An Observational Multicenter Study. AJNR Am J Neuroradiol 42(2):319\u0026ndash;326. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3174/ajnr.A6887\u003c/span\u003e\u003cspan address=\"10.3174/ajnr.A6887\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003eEpub 2020 Dec 10. PMID: 33303523; PMCID: PMC7872182\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePierot L, Barbe C, Thierry A, Bala F, Eugene F, Cognard C, Herbreteau D, Velasco S, Chabert E, Desal H, Aggour M, Rodriguez-Regent C, Gallas S, Sedat J, Marnat G, Sourour N, Consoli A, Papagiannaki C, Spelle L, White P (2022) Patient and aneurysm factors associated with aneurysm recanalization after coiling. J Neurointerv Surg 14(11):1096\u0026ndash;1101. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/neurintsurg-2021-017972\u003c/span\u003e\u003cspan address=\"10.1136/neurintsurg-2021-017972\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003eEpub 2021 Nov 5. PMID: 34740986; PMCID: PMC9606530\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDonnard B, Bala F, Boulouis G, Herbreteau D, Ifergan H, Barrot V, Giubbolini F, Bankole NDA, Hoche C, Bibi R, Janot K (2025) Safety of Ticagrelor Use in Elective Endovascular Treatment of Unruptured Intracranial Aneurysms. Neurosurgery. May 15. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1227/neu.0000000000003507\u003c/span\u003e\u003cspan address=\"10.1227/neu.0000000000003507\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Epub ahead of print. PMID: 40372047\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-7507868/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7507868/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eThe Low-profile visualized Intraluminal Support EVO (LVIS EVO) is a next-generation braided stent characterized by enhanced visibility and resheathability, and designed for stent-assisted coil embolization of intracranial aneurysms. Despite growing adoption, real-world data on its efficacy and safety remain limited.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003e This study aims to evaluate the safety and efficacy of the LVIS EVO stent in consecutive patients undergoing treatment for brain aneurysms.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eWe retrospectively analyzed all patients who underwent treatment of unruptured intracranial aneurysms with the LVIS EVO stent in a single tertiary center between January 2021 and January 2024. Baseline demographics, imaging and procedural characteristics, clinical outcomes, and clinical and radiological follow-up data were collected. The primary endpoints were successful deployment and complete aneurysm occlusion at follow-up as defined by the Raymond-Roy Occlusion Classification. Secondary endpoints included complication rate, modified Rankin Scale (mRS) at last clinical follow-up, and incidence of in-stent stenosis on last follow-up imaging.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eThirty-four patients (64.7% women; median age: 52 years) were treated for 34 saccular aneurysms. Most of the aneurysms were previously ruptured, and recanalized after initial treatment (20/34, 58.8%). They were located at the middle cerebral artery (15/34, 44.12%) or internal carotid artery terminus (8/34, 23.5%). Median aneurysm neck size was 3.3 mm, with an aspect ratio of 1.2 and a dome-to-neck ratio of 1.3. Stent deployment was successful in 100% of cases. Immediate complete occlusion (RROCs I) was achieved in 82.4% of aneurysms. At a median radiological follow-up of 24 months, 91.2% of aneurysms remained completely occluded, and 97.1% were adequately occluded (RROC I\u0026ndash;II). Two intraprocedural cases (5.9%) of in-stent thrombosis occurred and were managed successfully. One post-procedural symptomatic ischemic event occurred, but the patient was asymptomatic at the last clinical follow-up. There were no hemorrhagic or permanent ischemic complications. Asymptomatic in-stent stenosis occurred in 2 patients (5.9%). Clinical outcome was favorable (mRS\u0026thinsp;\u0026le;\u0026thinsp;2) in 100% of cases at last follow-up.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eThe LVIS EVO stent demonstrates excellent technical success and sustained aneurysm occlusion with a low complication rate. These results support its safety and efficacy in the treatment of intracranial aneurysms, including previously ruptured lesions and anatomically complex locations.\u003c/p\u003e","manuscriptTitle":"LVIS EVO Stent-Assisted Coiling for Intracranial Aneurysms: Results of Long-Term Follow-Up","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-15 06:24:45","doi":"10.21203/rs.3.rs-7507868/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f71ff58a-5c0a-406d-885f-01905630e4c8","owner":[],"postedDate":"September 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-11-24T16:07:35+00:00","versionOfRecord":{"articleIdentity":"rs-7507868","link":"https://doi.org/10.1007/s00234-025-03808-6","journal":{"identity":"neuroradiology","isVorOnly":false,"title":"Neuroradiology"},"publishedOn":"2025-11-18 15:57:02","publishedOnDateReadable":"November 18th, 2025"},"versionCreatedAt":"2025-09-15 06:24:45","video":"","vorDoi":"10.1007/s00234-025-03808-6","vorDoiUrl":"https://doi.org/10.1007/s00234-025-03808-6","workflowStages":[]},"version":"v1","identity":"rs-7507868","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7507868","identity":"rs-7507868","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}