Safety and effectiveness of ByCross Rotational Atherectomy and Aspiration Device: A prospective, multi-center pre-market approval study

AbstractPurposeTo demonstrate safety and effectiveness of the novel ByCross Atherectomy System for percutaneous treatment of TASC A-D de novo infrainguinal arterial >80% stenosis down to the tibioperoneal tract.Materials and Methods41 lesions were treated in this prospective, nonrandomized pre-market approval study across 2 German centers. Mean patient age was 72 years with 62% male. Average lesion length was 125±118 mm (30 to 450mm) with 96.4±6.2% stenosis. The primary performance endpoint was the acute procedural success defined as residual stenosis of ≤ 50% and ≤ 30% after atherectomy and adjunctive treatment. The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Secondary endpoints were DUS measured target lesion restenosis and the ABPI at discharge, 30 and 180 days and any MAE through 6 months.ResultsThe acute procedural success rate was 95.12% with 11/41 (26.82%) lesions being recanalized without wire guidance. Embolic protection was not used. Adjunctive POBA or stenting was used in 40/41 (97.56%) and 12/41 (29.26%), respectively. There were no MAE’s at 30 days. DUS measured mean residual stenosis was 5.7% at discharge and 21.7% at 6 months FU. Mean ABPI was 0.8, 1.0 and 0.8 at baseline, discharge, and 6 months FU respectively.ConclusionsThe ByCross Atherectomy System has shown to be safe and effective for the atherectomy of complex lower-extremity arterial lesions even without guidewire. Trial registration October 17, 2018 ,retrospectively registered. ClinicalTrials.gov Identifier: NCT03724279; https://clinicaltrials.gov/ct2/show/record/NCT03724279