Real-World Study Comparing Cutting Balloons and Drug-Coated Balloons for Treating Narrowing in Autologous Arteriovenous Fistulas

What this Trial Is About

Researchers are evaluating the effectiveness and safety of cutting balloons compared to drug-coated balloons in treating venous segment stenosis in autologous arteriovenous fistulas. This prospective, multi-center cohort study aims to understand which treatment provides better outcomes for patients undergoing hemodialysis access failure. The study will enroll 180 patients between June 2024 and December 2025 across multiple centers. Participants will be divided into two groups based on the treatment they receive one group treated with cutting balloons and the other with drug-coated balloons. Both treatments use endovascular therapy, a minimally invasive procedure that accesses the vascular system to treat the stenosis without open surgery. The study will track the success of these devices and monitor any major adverse events during and after the procedures. Throughout the study, patients will be followed up at 1, 3, 6, and 12 months after treatment to evaluate target lesion re-intervention rates, primary patency rates, and assisted primary patency rates of the treated vessels. Researchers will assess clinical success, monitor complications, and collect data on the technical and procedural success of each device. The total duration of participation will last up to 12 months after the intervention to ensure comprehensive outcome measurement.

Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure