Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial

Conditions
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Peripheral Vascular Disease, Intermittent Claudication, Atherosclerosis, Angioplasty

Intervention / Treatment
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* Procedure: angioplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: angioplasty|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of restenosis within 6 months after endovascular treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral vascular disease, percutaneous transluminal angioplasty, cutting balloon, balloon angioplasty, randomized controlled trial, restenosis, inflammation