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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00437905
Other study ID # Version 2.0-12/2003
Secondary ID
Status Terminated
Phase Phase 4
First received February 20, 2007
Last updated February 20, 2007
Start date June 2003
Est. completion date January 2007

Study information

Verified date February 2007
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
angioplasty


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Outcome

Type Measure Description Time frame Safety issue
Primary course of postintervention inflammation as indicated by serum levels of C-reactive Protein (CRP+ us-CRP)
Secondary occurence of restenosis within 6 months after endovascular treatment
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