Comparing Drug-Coated Balloons and Cutting Balloons for Treating Venous Narrowing in Arteriovenous Fistulas Effectiveness and Safety Study in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two types of balloon treatmentscutting balloons and drug-coated balloonsfor venous stenosis in autologous arteriovenous fistulas used for hemodialysis. The study aims to determine whether drug-coated balloons offer better outcomes in terms of reducing the need for repeat procedures and to understand medical issues that may occur during treatment. The study will include 180 patients divided into two groups based on the treatment they receive one group treated with cutting balloons and the other with drug-coated balloons. The treatments involve endovascular therapy, a minimally invasive procedure using catheters to access and treat the narrowed vein segments. The primary focus will be on patency rates and re-intervention rates at 1, 3, 6, and 12 months after the procedure, along with technical and procedural success and monitoring for major adverse events. Participants will be followed closely with evaluations at multiple time points to assess the condition of the treated arteries and veins. Researchers will track outcomes like the number of participants needing another procedure and how well the treated blood vessels remain open. The study will also monitor any complications during the perioperative period. The entire study will take place between June 2024 and December 2025, with follow-up assessments up to 12 months after treatment.

DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis