Effectiveness and Health Economics of Endoluminal Treatment of Arteriovenous Graft Fistula.

Recruiting now

Conditions studied: Hemodialysis Access Failure

In brief

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.

Key facts

Study ID

NCT06470646

Run by

RenJi Hospital

People needed

240

Starts

2023-09-01

Expected to finish

2026-12-31

Last updated by the study team

2024-06-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18 to 80 years undergoing hemodialysis;
• Patients with arteriovenous graft fistula unable to complete hemodialysis;
• 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;
• Patients who have successfully undergone endovascular treatment again after the initial target lesion opening failure are still eligible for inclusion;
• 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.

You may not qualify if…

• Planned kidney transplant or conversion to peritoneal dialysis
• Women who are pregnant,breastfeeding or planning to become pregnant during the study period
• Recent (within 30 days) or planned surgical procedure for haemodialysis access
• Allergy or contraindication to heparin, contrast media, antiplatelet drugs
• Patients who have participated in a clinical trial of a drug or other medical device that interferes with this clinical trial within the last 3 months.
• Patients with a history of coagulation disorders or other haematological disorders
• Patients with other conditions that may make the trial difficult or significantly shorten the patient's life expectancy (<2 years), e.g.tumours,severe liver disease,cardiac insufficiency,etc.,or patients with a life expectancy of less than 6 months.
• Patients unable or unwilling to participate in this trial

Where it is running

• Renji Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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