Evaluating endovascular treatments for arteriovenous graft fistula failure

A Real-World Clinical Study Based on Decentralized Arteriovenous Fistula Data System - Endovascular Treatment Efficacy and Health Economics Evaluation of Failure in Arteriovenous Graft Fistula.

This study is testing different endovascular treatments for patients with arteriovenous graft fistula failure to see which methods work best and how they affect overall health and costs.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06470646 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and health economics of various endovascular treatment methods for patients experiencing arteriovenous graft fistula failure. It will recruit 240 patients at RenJi Hospital in Shanghai from September 2023 to December 2024, categorizing them into subgroups based on the treatment method used, such as balloon dilation or stent implantation. The study will focus on measuring technical success rates, adverse events, and the need for further interventions, providing insights into the real-world application of these treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 undergoing hemodialysis with arteriovenous graft fistula failure.

Not a fit: Patients planning a kidney transplant or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve treatment outcomes and cost-effectiveness for patients with hemodialysis access failure.

How similar studies have performed: Other studies have shown promise with endovascular treatments for similar conditions, suggesting potential for success in this approach.

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 haemodialysis access
4. Allergy or contraindication to heparin, contrast media, antiplatelet drugs
5. 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.
6. Patients with a history of coagulation disorders or other haematological disorders
7. 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.
8. Patients unable or unwilling to participate in this trial

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Principal investigator: JiaQuan Chen, M.M. — RenJi Hospital
• Study coordinator: Cao Ruzhou

Conditions Hemodialysis Access Failure