Status:
COMPLETED
Drug Eluting Balloon Angioplasty for Dialysis Access Treatment
Lead Sponsor:
University of Patras
Conditions:
Dialysis
Angioplasty
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
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 tre...
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 angiopla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01174472
Start Date
March 1 2010
End Date
January 1 2012
Last Update
January 23 2012
Active Locations (1)
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1
Patras University Hospital, Department of Radiology, Angiography Suite
Rio, Achaias, Greece, 26504