Comparing Paclitaxel-Coated Balloon Angioplasty and Primary Selective Stenting for TASC CD Chronic Femoropopliteal Artery Disease

What this Trial Is About

Researchers are evaluating the mid- and long-term results of two treatments for patients with TASC CD chronic femoropopliteal artery occlusive disease. This condition involves blockages in the femoral and popliteal arteries. The study aims to compare the outcomes between using a paclitaxel-coated balloon and primary selective stenting. This is a multicenter randomized clinical trial sponsored by Peking Union Medical College Hospital. Participants in this trial are randomly assigned to one of two groups. One group receives paclitaxel-coated balloon angioplasty, which may include bailout stenting if needed. The other group undergoes primary selective stenting using bare metal stents. The treatments focus on arteries with lesions not exceeding 30 cm in length and specific vessel size criteria. The study does not use masking or blinding. During the trial, participants will be monitored for the primary outcome of the one-year primary patency rate, which assesses how well the treated artery remains open. Secondary outcomes include the need for clinical-driven target lesion revascularization at one, two, and three years. Follow-up visits and required tests will be conducted according to the study schedule. Participants must agree to attend these visits and complete the testing throughout the study period, which lasts up to several years to evaluate mid- and long-term effects.

DCB Versus Primary Selective Stenting in TASC C/D Femoropopliteal Artery Disease