Evaluating endovascular treatments for arteriovenous graft fistula failure

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: JiaQuan Chen, M.M. — RenJi Hospital
• Study coordinator: Cao Ruzhou
• Email: caorzh@126.com
• Phone: +86-18616752813

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.

  Recruiting at 3 sites RenJi Hospital · Zhengzhou, Henan and 2 other locations · NCT06527963

• 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 failed arteriovenous fistulas in hemodialysis patients

  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.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT06454396

• 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.