Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Patras
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Technical success
Study Overview
Brief Summary
The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.
Detailed Description
In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Angiographic and clinical diagnosis of dysfunctional dialysis access due to one or more stenotic lesions.
- •Patients with AVF or AVG
- •Fistula or graft or vessel diameter ranging from 3 mm up to 12 mm
Exclusion Criteria
- •Fistula or graft or vessel diameter < 3 mm and > 12 mm
- •History of severe allergic reaction to contrast media
- •Intolerance to aspirin and/or clopidogrel
- •Systemic coagulopathy or hypercoagulation disorders
Arms & Interventions
Conventional Balloon Angioplasty (COBA)
Patients with lesions treated with conventional balloon angioplasty
Intervention: Percutaneous Transluminal Angioplasty (PTA) (Device)
Drug Eluting Balloon Angioplasty (DEB)
Patients with lesions treated with Drug Balloon Angioplasty
Intervention: Percutaneous Transluminal Angioplasty (PTA) (Device)
Outcomes
Primary Outcomes
Technical success
Time Frame: 1 minute after the final balloon angioplasty
Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography
Primary patency
Time Frame: 1 year
Angiographic visualization of a lesion with \<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access.
Secondary Outcomes
- Secondary patency(1 year)
- Target lesion re-intervention (TLR)-free interval(1 year)
- Major complications rates(Periprocedural and up to 1 year)
- Minor complications rates(Periprocedural and up to 1 year follow-up)
Investigators
SIABLIS DIMITRIOS
Professor of Radiology
University of Patras