Cutting Balloons vs Drug-Coated Balloons for Fistula Stenosis

DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis

Recruiting Observational Study
Arteriovenous Fistula Angioplasty, Balloon Hemodialysis Access Failure
No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Study type
Observational
Participants needed
180 (estimated)
Sponsor
RenJi Hospital · Other
Who this trial is looking for

This trial is looking for adults with a type of blood vessel narrowing in their arm due to hemodialysis access. Participants will receive either a cutting balloon or a drug-coated balloon to see which treatment works better and what issues may arise.

Are You a Good Fit for This Trial?
Rules you out CoagulopathyVasculitis

You may be able to join if

  • I am between 18 and 75 years old.
  • I have a mature upper limb arteriovenous fistula (AVF).
  • I have had at least one hemodialysis session.
  • I have a venous narrowing (stenosis) that is confirmed to be 50% or more.
  • I have certain problems during dialysis, like high venous pressure.
  • I can give my informed consent to participate.
  • I am willing to follow up as required by the trial.

You may not be able to join if

  • My narrowing is in the artery section of the AVF.
  • I have had a stent placed in my AVF.
  • I have signs of a serious central vein blockage.
  • I have two or more narrow areas in my AVF.
  • I had a blood clot in my AVF or related treatment in the past 30 days.
  • I plan to have surgery on my AVF in the next 30 days.
  • I have an infection in my AVF or another active systemic infection.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial
The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are: 1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons? 2. What medical problems do participants have when receiving treatment with drug-co…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Subjects aged between 18 and 75 years. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session. Target lesion must be located in the venous segment of the upper limb AVF. Doppler ultrasound confirms that t…
Contacts

RuZhou Cao

+86 18616752813

caorzh@126.com

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