NCT00715416CompletedPhase 4
Balloon Angioplasty vs. Primary Stenting of Femoropopliteal Arteries Using Self-Expandable Nitinol Stents - a Randomized Controlled Trial
Vienna General Hospital2 sites in 1 country76 target enrollmentStarted: June 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 76
- Locations
- 2
- Primary Endpoint
- occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).
Study Overview
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 with optional secondary stenting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis).
Time Frame: 3, 6, 12 months
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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