JPRN-UMIN000021844RecruitingPhase 4
Innovative endovascular treatment strategy by angiography, IVUS and pressure gradient guidance in SFA disease with a new nitinol stent system -A prospective multicenter study- - IGNITE study
Japan Endovascular Treatment Conference0 sites300 target enrollmentStarted: April 9, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
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%)
Investigators
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