PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents
Phase 4
Completed
- Conditions
- Intermittent ClaudicationPeripheral Vascular DiseasesAngioplasty
- Registration Number
- NCT00715416
- Lead Sponsor
- Vienna General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method occurrence of a >50% restenosis at the treated segment at 6 months postintervention as determined by CTA (in-segment restenosis). 3, 6, 12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University Hospital of Vienna
🇦🇹Vienna, Austria
University Hospital of Vienna🇦🇹Vienna, Austria