Intermittent Claudication Clinical Trial
Official title:
Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial
Verified date | January 2006 |
Source | Vienna General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Agency for Health and Food Safety |
Study type | Interventional |
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 with optional secondary stenting.
Status | Completed |
Enrollment | 76 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | University Hospital of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Vienna General Hospital |
Austria,
Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis). | 3, 6, 12 months | Yes | |
Secondary | ultrasound patency, clinical patency, target vessel and target lesion revascularization, cardiovascular events, quality of life at 3, 6 and 12 months after the procedure | 3, 6, 12 months | Yes |
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