Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Disease
- Sponsor
- Medical University of Vienna
- Enrollment
- 40
- Primary Endpoint
- course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
- Status
- Terminated
- Last Updated
- 19 years ago
Overview
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-term-results are disappointing as restenosis may frequently occur. One of the hypothesis for the differences in the reported patency rates is that the amount of vessel trauma correlates directly to the prognosis (restenosis) of the treated vessel wall segment. With the introduction of cutting balloons the problems of elastic recoil and residual stenosis might be resolved, by reduction of vessel wall trauma, vessel wall inflammation and consequently reduced neointima formation. The promising results especially in coronary arteries led us to initiate a RCT comparing primary PTA vs. CB-PTA for treatment of femoropoliteal obstructions in patients with intermittent claudication or critical limb ischemia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Severe intermittent claucication (Fontaine stage IIb)or limb ischemia, femoropoliteal stenosis/occlusion up to 5 cm length
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
Secondary Outcomes
- occurence of restenosis within 6 months after endovascular treatment