Innovative endovascular treatment strategy by angiography, IVUS and pressure gradient guidance in SFA disease with a new nitinol stent system -A prospective multicenter study
Phase 4
Recruiting
- Conditions
- Symptomatic peripheral artery disease: -Moderate or severe claudication (Rutherford category 2 or 3) -Critical limb ischemia (Rutherford category 4 or 5)
- Registration Number
- JPRN-UMIN000021844
- Lead Sponsor
- Japan Endovascular Treatment Conference
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
1) Acute critical limb ischemia 2) Severe critical limb ischemia (Rutherford category 6) 3) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel 4) Age < 20 years 5) Life expectancy <2 year due to comorbidity 6) Severe dementia or bedridden case Angiographic criteria 1) Target lesion length > 150 mm by angiographic estimation (TASC II C and D lesion) 2) Previous bypass surgery or stenting of the superficial femoral artery 3) Diseased CFA or distal popliteal artery (P2 or P3 segment) with stenosis more than 50%)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method