Status:
COMPLETED
PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
Lead Sponsor:
Vienna General Hospital
Conditions:
Peripheral Vascular Diseases
Intermittent Claudication
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty ...
Eligibility Criteria
Inclusion
- symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
- critical limb ischemia in patients with stenosis or occlusions originating in the SFA
- up to 25 cm length of stenosis/occlusion
Exclusion
- previous bypass surgery at the site of treatment
- history of intolerance of anti-platelet therapy
- adverse reaction to heparin
- bleeding diathesis
- creatinine \>2.5 mg/dL
- active bacterial infection
- allergy to contrast media
- previous stent placement at or immediately adjacent to the target lesion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00715416
Start Date
June 1 2004
End Date
February 1 2008
Last Update
July 15 2008
Active Locations (1)
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1
University Hospital of Vienna
Vienna, Vienna, Austria, 1090