Balloon angioplasty versus stenting with nitinol stents in the superficial femoral artery
Completed
- Conditions
- Peripheral artery disease, superficial femoral artery stenosis or occlusionCirculatory System
- Registration Number
- ISRCTN52947529
- Lead Sponsor
- Medical University Vienna (Austria)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
1. Symptomatic peripheral artery disease - Rutherford stages 3 to 5
2. >50% Stenosis of the ipsilateral superficial femoral artery
3. Lesion length >30 mm
4. At least one patent crural runoff vessel
Exclusion Criteria
1. Acute critical limb ischemia
2. Previous ipsilateral bypass surgery or ipsilateral superficial femoral artery (SFA) stenting
3. Untreated inflow disease
4. Known intolerance to clopidogrel, aspirin or radiocontrast
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Angiographic restenosis at six months
- Secondary Outcome Measures
Name Time Method 1. Restenosis by duplex ultrasound at 3, 6 and 12 months<br>2. Walking distance on the treadmill at 3, 6 and 12 months<br>3. Ankle brachial index at 3, 6 and 12 months<br>4. Stent fractures at 6 and 12 months