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Clinical Trials/JPRN-UMIN000021844
JPRN-UMIN000021844
Recruiting
Phase 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 enrollmentApril 9, 2016

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Symptomatic peripheral artery disease: -Moderate or severe claudication (Rutherford category 2 or 3) -Critical limb ischemia (Rutherford category 4 or 5)
Sponsor
Japan Endovascular Treatment Conference
Enrollment
300
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 9, 2016
End Date
December 31, 2018
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Japan Endovascular Treatment Conference

Eligibility Criteria

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%)

Outcomes

Primary Outcomes

Not specified

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