Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.
Trial Parameters
Brief Summary
This study is a prospective, single-center real-world research, aiming to understand the clinical intervention effects and health economics value of various endovascular treatment methods for arteriovenous graft fistula failure in the real world. The target lesion is defined as the inflow tract (artery, anastomosis, bend), middle segment, and outflow vein of the dialysis pathway. The study will recruit 240 patients with arteriovenous graft fistula failure at a single center from September 2023 to December 2024. Depending on different treatment methods, patients will be divided into several subgroups, such as the simple balloon dilation group, drug balloon group, stent implantation group, etc. As this is a real-world study, the main observations will be the technical success rate of various endovascular treatment methods, major adverse events during the perioperative period, and the symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospital expenditure related to target lesions at 1, 6, 12, 18, and 24 months postoperatively.
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 80 years undergoing hemodialysis; 2. Patients with arteriovenous graft fistula unable to complete hemodialysis; 3. The guidewire must pass through the stenosis of the lesion side's graft fistula and further undergo endovascular treatment to be eligible for inclusion. This study does not limit the form of guidewire passing through the target lesion; 4. Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion; 5. Subjects and their legal representatives understand the purpose of the study, voluntarily participate, and sign informed consent forms, willing to undergo follow-up at specific time points in this trial. Exclusion Criteria: 1. Planned kidney transplant or conversion to peritoneal dialysis 2. Women who are pregnant,breastfeeding or planning to become pregnant during the study period 3. Recent (within 30 days) or planned surgical procedure for ha