Prospective Randomized Trial Comparing Drug Eluting Balloon Angioplasty Versus Conventional Percutaneous Transluminal Angioplasty Balloon for the Treatment of Hemodialysis Arterio-Venous Fistula or Arterio-Venous Graft Stenoses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Singapore General Hospital
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Late luminal loss
Study Overview
Brief 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.
Detailed Description
Introduction:
Neointimal hyperplasia is the main cause of hemodialysis access [arterio-venous fistula (AVF) or graft (AVG)] dysfunction and thrombosis. Although endovascular techniques like percutaneous transluminal angioplasty (PTA), catheter directed thrombolysis, mechanical thrombectomy or bare metal stenting, may salvage the access, long term patency remains dismal due to recurrent stenosis from neointimal hyperplasia.
Drug Eluting Balloon (DEB) is effective in inhibiting neointimal hyperplasia for treatment of coronary in-stent restenosis since 2006 and more recently in femoropopliteal arteries, reducing restenosis rates and prolonging patency.
Specific Aim:
To determine the efficacy of DEB in reducing restenosis rates and prolonging the patency of AVFs/AVGs compared to PTA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional PTA only
Treatment Arm 1- Conventional PTA only
The conventional balloon is used and the diameter of the balloon should be the same or oversized by 1mm the diameter of the reference vessel.
An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 2 minutes.
At the end of the first angioplasty, an AVFistulogram/AVGraftogram will be obtained to document results. If there is residual stenosis of >30%, a repeat angioplasty using the same balloon or another appropriately oversized balloon by 1mm will be used for an additional 2 minutes. A final angiogram will be obtained for documentation.
Intervention: Conventional PTA (Device)
Drug Eluting Balloon (DEB)
Treatment arm 2 - Conventional Balloon with DEB
A Conventional balloon is used to pre-dilate the target lesion. The DEB of a similar diameter to the conventional balloon used is then inflated across the stenosis. An inflation device with a pressure gauge is used to inflate up to manufacturers' stated burst pressure. The duration of balloon inflation will be 1 minute. A final angiogram will be obtained for documentation. The drug coated on the DEB is Paclitaxel.
Intervention: Drug Eluting Balloon (DEB) (Device)
Outcomes
Primary Outcomes
Late luminal loss
Time Frame: 6 months
Late luminal loss is defined as the difference between the minimum lumen diameters after angioplasty and at the end of the 6-month follow-up angiogram.
Secondary Outcomes
- Secondary patency(6 months)
- Clinical success(Immediate post procedure)
- Primary patency(6 months)
- Primary assisted patency(6 months)
- Restenosis rate(6 months)
- Anatomic success(Immediate post procedure)
- Procedural success(Immediate post procedure)