Study on Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Catheter for Treating Hemodialysis Arteriovenous Fistula Narrowing

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in treating stenosis of arteriovenous fistulas used for hemodialysis. This prospective, multi-center, single-arm clinical study plans to enroll 328 participants who have mature arteriovenous fistulas or grafts with significant narrowing. The study aims to measure how well the treated blood vessel remains open, focusing on the primary patency of the target lesion six months after the procedure. Participants will receive treatment using the Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter during a surgical procedure. After treatment, participants will have follow-up visits within 5 days, then at 1 month, 6 months, and later at 12, 18, and 24 months to monitor the treated area. The primary goal is to assess the blood vessels openness at 6 months, with additional checks extending up to two years to evaluate longer-term outcomes. During the study, participants will undergo various assessments including Doppler ultrasound to measure blood flow and detect restenosis, evaluations of clinical success shortly after the procedure, and checks for the need for further revascularization treatments. Safety and technical success of the device will also be monitored immediately after the intervention. The total participation time spans up to 24 months, allowing detailed observation of the devices performance and the participants vascular health over time.

Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis