A novel ultrasound controlled paclitaxel releasing balloon catheter versus plain balloon catheter in the treatment of small coronary vessel stenosis: study protocol of a randomized controlled clinical trial (Vasoguard I Trial)

Abstract Background The optimal intervention strategy remains controversial in small vessel disease which is a very common kind of coronary artery lesions. For now, balloon-only percutaneous coronary intervention is the major percutaneous revascularization method in these patients, but the restenosis rate is still at a high level. Drug coated balloon is designed to deliver paclitaxel to target vessel to inhibit the proliferation of vascular endothelial cells, it aims at restraining the stenosis process after intervention so as to reduce the rate of restenosis. Ultrasound controlled paclitaxel releasing balloon catheter (Vasoguard TM ) is a newly designed drug coated balloon, expected to promote the drug release process via external ultrasound intervention so as to improve drug bioavailability. The current trial was designed to assess the efficacy and safety of Vasoguard in the treatment of small vessel coronary disease.Methods A prospective, multicenter, randomized, controlled clinical trial has been designed to compare the safety and efficacy of Vasoguard with plain balloon angioplasty in the treatment of small vessel coronary disease. 230 patients will be included in this trial, the primary endpoint is late lumen loss of target lesion at 9 months post operation measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as device success rate, operation success rate, in-segment restenosis, clinical outcomes such as target lesion revascularization, target vessel revascularization, device oriented composite endpoint and thrombotic events.Discussion This trial will evaluate the efficacy and safety of Vasoguard in the treatment of small vessel coronary disease by comparing to plain balloon angioplasty. It will clarify the practicability of the newly designed balloon and may lend more credence to the role of drug coated balloon in the treatment of small vessel disease.