Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure in a Real-World Clinical Study

What this Trial Is About

Researchers are evaluating different endovascular treatments for patients with autologous arteriovenous fistulae that have lost function, which is important for hemodialysis access. This prospective, single-center, real-world study aims to understand the clinical effectiveness and health economic impact of various treatment methods for early and mid-stage fistula failure. The study will enroll 480 patients between 18 and 80 years old who have failed autologous arteriovenous fistulae. Participants will be divided into groups based on treatment type, including balloon dilatation alone, medicated balloon, and stent implantation. The study focuses on the target lesion in the hemodialysis access inflow tract, intermediate segment, and outflow vein. Treatments are minimally invasive, using specialized catheters and devices without open surgery. Participants will be followed for up to 24 months with assessments at 1, 6, 12, 18, and 24 months after treatment. Researchers will measure rates of technical success, adverse events, symptom-driven repeat interventions, vessel patency, and total hospitalization costs related to the target lesion. The main outcome is clinically-driven target lesion re-intervention over the 24-month period, along with primary and assisted primary patency rates. Participants will provide informed consent and undergo regular follow-up visits.

Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure