Drug-eluting Balloon for Treatment of Non-atherosclerotic Renal Artery Stenosis——a Multi-center Study

Introduction Renal artery stenosis (RAS) is a significant reason for secondary hypertension. Impaired renal function and subsequent cardiopulmonary dysfunction could also occur. Patients of non-atherosclerotic RAS has a relatively young age and long life expectancy. Revascularization with percutaneous transluminal angioplasty (PTA) is a viable treatment option. However, restenosis is unavoidable which limits its use. Drug-eluting balloon (DEB) has been proven to be effective in restenosis prevention in femoropopliteal arterial diseases and in patients with non-atherosclerotic RAS. Therefore, we could speculate that DEB might have potential efficacy in non-atherosclerotic RAS treatment. Methods and analysis This will be a randomized multi-center controlled trial. Eighty-four eligible participants will be assigned randomly in a 1:1 ratio to the control group (POB) and the experimental group (DEB). Subjects in the former group will receive balloon dilatation alone, and in the latter group will undergo the DEB angioplasty. The DEB used in this study will be a paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China). Follow-up visits will be scheduled 1, 3, 6, 9, and 12 months after the intervention. Primary outcomes will include clinical benefits and primary patency in the 9-month follow-up. Secondary outcomes will include technical success rate, complication rate, and bail-out stenting rate. Trial registration number ClinicalTrials.gov (number NCT 05858190) Protocol version V.4 (3 May 2023).