Evaluating endovascular treatments for failed arteriovenous fistulas in hemodialysis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jingpu Zhu
• Email: a8600809@163.com
• Phone: +86-17520505530

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing drug-coated balloons and cutting balloons for treating arteriovenous fistula stenosis

  This study is testing whether drug-coated balloons or cutting balloons work better and are safer for treating narrowing in arteriovenous fistulas in patients.

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• Comparing cutting balloons and drug-coated balloons for treating fistula failure

  This study is testing whether cutting balloons or drug-coated balloons work better for treating problems in arteriovenous fistulas in patients with venous segment stenosis.

  Recruiting at 3 sites RenJi Hospital · Zhengzhou, Henan and 2 other locations · NCT06493292

• Evaluating endovascular treatments for arteriovenous graft fistula failure

  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.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT06470646

• Observational study of HeRO Graft and Super HeRO in hemodialysis patients

  This study is testing how safe and effective the HeRO Graft System and Super HeRO Adaptor are for adults on hemodialysis who have run out of other options for dialysis access.

  Recruiting at 7 sites Merit Medical Systems, Inc. · Washington D.C., District of Columbia and 6 other locations · NCT06422871

• SelfWrap-Assisted Arteriovenous Fistulas for Chronic Kidney Disease

  This study is testing if a new wrap called SelfWrap can make it safer and more effective for people with chronic kidney disease to have a new arteriovenous fistula created.

  Recruiting at 28 sites VenoStent · Bullhead City, Arizona and 27 other locations · NCT06001827

• Analysis of sounds from vascular access in dialysis patients

  This study is testing whether listening to the sounds from different types of vascular access can help doctors understand how well they work for patients on dialysis.

  Recruiting Mario Negri Institute for Pharmacological Research · Bergamo, BG · NCT05612022

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.