Evaluating endovascular treatments for failed arteriovenous fistulas in hemodialysis patients

A Real-world Clinical Study Based on a Decentralized Arteriovenous Endovascular Fistula Data System - Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure

This study is testing different treatments for patients with failing arteriovenous fistulas used in hemodialysis to see which ones work best and how they affect healthcare costs.

Quick facts

• Study type: Observational
• Enrollment: 480 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06454396 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness and health economic implications of various endovascular treatments for patients experiencing failure of autologous arteriovenous fistulas used for hemodialysis. It will enroll 480 patients at a single center, RenJi Hospital, and categorize them based on treatment modalities such as balloon dilatation, medicated balloons, and stent implantation. The study will monitor technical success rates, major adverse events, re-intervention rates, vessel patency, and hospitalization costs over a period of 24 months.

Who should consider this trial

Good fit: Ideal candidates are hemodialysis patients aged 18 to 80 with failed autologous arteriovenous fistulas.

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 options and economic outcomes for patients with hemodialysis access failure.

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

Eligibility criteria

Inclusion Criteria:

1. Hemodialysis patients over 18 years of age and under 80 years of age
2. Autologous arteriovenous fistula cannot be used in patients completing haemodialysis
3. The guidewire must pass through at least the stenosis of the endovascular fistula on the side of the lesion and undergo further endovascular treatment before enrolment, and this study does not limit the form of the guidewire passing through the target lesion.
4. Patients who have failed to open the initial target lesion and are successful on a second attempt at endoluminal therapy may still be enrolled.
5. Subjects and their legal representatives are able to understand the purpose of the study, participate voluntarily and sign an informed consent form, and are willing to be followed up at specific points in time.

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

• Study coordinator: Jingpu Zhu

Conditions Hemodialysis Access Failure