Phase 3 Randomized Study Comparing Drug-Coated Balloon Angioplasty to Conventional Balloon Angioplasty for Peripheral Arteriovenous Fistula Stenosis

What this Trial Is About

This research aims to compare the effectiveness of two types of balloon angioplasty treatments for patients with narrowing stenosis in their arteriovenous fistula AVF, which is used for dialysis access. The study focuses on the primary patency, meaning how long the access remains open without further narrowing, after treatment using either a drug-coated balloon Ranger or a conventional balloon. This trial is a blinded, randomized controlled study involving patients with AVF stenosis. Participants will be randomly assigned in equal numbers to receive angioplasty with either the Ranger drug-coated balloon or a conventional balloon. All peripheral AVF narrowings will be treated using the assigned balloon type. The study includes a primary outcome measure of access circuit primary patency assessed at 6 months, with additional secondary outcomes measured at 6, 12 months, and longer term. During the study, patients will be monitored for how well their dialysis access remains open, any complications from the procedure, and overall mortality up to 5 years. The study involves follow-up assessments to evaluate the success of the angioplasty treatments and the condition of the AVF over time. Participants are expected to be adults aged 21 or older who meet specific criteria related to their AVF condition and treatment suitability.

Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis