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

Phase 4

Terminated

• Conditions: Angioplasty; Peripheral Vascular Disease; Intermittent Claudication; Atherosclerosis

• Registration Number: NCT00437905
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2003-06
• Study Completion: 2007-01
• Status Verified: 2007-02
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Last Update Submitted: 2007-02-20
• Study First Posted: 2007-02-21
• Last Update Posted: 2007-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)

Secondary Outcome Measures

Name	Time	Method
occurence of restenosis within 6 months after endovascular treatment