Atherosclerosis Clinical Trial
Official title:
Balloon Angioplasty vs. Cutting Balloon Angioplasty of Femoropopliteal Arteries- a Randomized Controlled Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
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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