Randomized Clinical Trial Comparing Scoring Balloon and High Pressure Balloon for Treating Narrowing in Hemodialysis Arteriovenous Grafts

What this Trial Is About

Researchers are conducting a multicenter, prospective, randomized controlled study to evaluate treatments for hemodialysis arteriovenous graft stenosis. The goal is to determine whether a scoring balloon catheter is superior to a high pressure balloon catheter in treating these narrowing lesions, helping to optimize patient care. The study involves 140 patients across seven clinical centers. Participants will be randomly assigned to receive treatment with either the DKutting PTA Scoring Balloon Dilatation Catheter, which uses scoring elements to focus expansion force at lower pressure, or a Peripheral Balloon Catheter inflated to a specific diameter and pressure. After the procedure, patients will be followed up clinically at 5 days, 3 months, 6 months, and 12 months to monitor outcomes. Throughout the study, researchers will assess measures such as Target Lesion Primary Patency at 6 and 12 months, Access Circuit Primary and Secondary Patency, acute lumen gain during the procedure, and technical and clinical success shortly after treatment. These evaluations aim to track the effectiveness and durability of the treatments over one year, with safety and performance monitored closely during follow-up visits.

Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis