Status:
TERMINATED
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
Lead Sponsor:
Medical University of Vienna
Conditions:
Peripheral Vascular Disease
Intermittent Claudication
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study to compare balloon angioplasty (PTA) vs. cutting balloon angioplasty (CB-PTA) in terms of patency and postintervention inflammation in peripheral artery disease.
Detailed Description
Balloon Angioplasty is a minimal invasive technique for treatment of superficial femoropoliteal artery obstructions. Despite high initial success rate and an acceptably low complication rate, long-ter...
Eligibility Criteria
Inclusion
- Severe intermittent claucication (Fontaine stage IIb)or limb ischemia, femoropoliteal stenosis/occlusion up to 5 cm length
Exclusion
- Previous bypass surgery at the site of treatment,
- Previous stent placement at or immediatly adjacent to target lesion,
- History of anti-platelet-therapy intolerance or adverse reaction to heparin,
- Bleeding diathesis,
- Creatinine \> 2,5 mg/dL,
- Active bacterial infection,
- Allergy to contrast media
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00437905
Start Date
June 1 2003
End Date
January 1 2007
Last Update
February 21 2007
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