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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2007-01-31

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.

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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.

Conditions

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Peripheral Vascular Disease Intermittent Claudication Atherosclerosis Angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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angioplasty

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No