CompletedNot Applicable

Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses

Singapore125 participantsStarted 2012-01

Plain-language summary

A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty versus conventional percutaneous transluminal angioplasty balloon for the treatment of hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Upper limb or groin AVF/AVG
✓. The AVF/AVG is \> 3 months old.
✓. Native vessel measures between 4 to 7 mm diameter (corresponding to the sizes of available DEBs).
✓. The fistula or graft must not be thrombosed.
✓. Able to cross with guide wire
✓. Platelet count \>50,000/l (platelet infusion if \<100,000/l)
✓. PT/PTT not more than 3 seconds above normal (FFP infusion for abnormal PT/PTT)

Exclusion criteria

✕. Uncorrectable coagulopathy (despite transfusion) or hypercoagulable state.
✕. Evidence of systemic infection or a local infection associated with the fistula or graft.
✕. The patient is \< 21 years of age.
✕. The patient is pregnant.
✕. Patient is enrolled in another investigational study
✕. Patient has comorbid conditions that may limit their ability to comply with the follow-up requirement.
✕. Life expectancy \< 6 months

What they're measuring

Late luminal loss

Timeframe: 6 months

Trial details

NCT IDNCT01544907

SponsorSingapore General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Stenosis of Arteriovenous Dialysis Fistula trials