Unique ID issued by UMIN | UMIN000021844 |
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Receipt number | R000025094 |
Scientific Title | Innovative endovascular treatment strategy by angiography, IVUS and pressure gradient guidance in SFA disease with a new nitinol stent system -A prospective multicenter study- |
Date of disclosure of the study information | 2016/04/09 |
Last modified on | 2017/10/10 13:07:26 |
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
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 |
Symptomatic peripheral artery disease:
-Moderate or severe claudication (Rutherford category 2 or 3)
-Critical limb ischemia (Rutherford category 4 or 5)
Cardiology | Vascular surgery |
Others
NO
The primary objective is to evaluate the optimal endovascular therapy for SFA disease with strictly defined bail-out stent implantation. Under this bail out stent criteria, we will clarify what proportion of endovascular cases need bailout stent implantation
Safety,Efficacy
Confirmatory
Explanatory
Phase IV
Primary patency of optimal balloon and bail-out stent at 12months which was defined as freedom from restenosis by DUS at rest peak systolic velocity ratio (PSVR) less than 2.5 with no reintervention
1) Freedom from Clinically Driven Target lesion revascularization
2) All-cause mortality
3) Myocardial infarction
4) Brain infarction
5) Freedom from conversion to bypass surgery involving the target lesion
6) Amputation free rate
7) Improve of Rutherford category
8) Ankle-brachial index at 12months
9) Primary patency at 6 months
10) Technical successful rate
11) Complication free rate
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Age 20 years or older
2) Symptomatic peripheral artery disease:
-Moderate or severe claudication (Rutherford category 2 or 3)
-Critical limb ischemia (Rutherford category 4 or 5)
3) Patients with signed informed consent
Anatomical criteria:
1) Target lesion length <150 mm by angiographic estimation (TASC II A and B lesion)
2) Significant Stenosis or occlusion of the superficial femoral artery
3) De novo lesion
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%)
300
1st name | |
Middle name | |
Last name | Masahiko Fujihara |
Kishiwada Tokushukai Hospital
Cardiology
4-27-1 Kamoricho Kishiwada
072(445)9915
masahiko-fujihara@themis.ocn.ne.jp
1st name | |
Middle name | |
Last name | Masahiko Fujihara |
Kishiwada Tokushukai Hospital
Cardiology
4-27-1 Kamoricho Kishiwada
072(445)9915
masahiko-fujihara@themis.ocn.ne.jp
Japan Endovascular Treatment Conference
Japan Endovascular Treatment Conference
Other
NO
2016 | Year | 04 | Month | 09 | Day |
Unpublished
Open public recruiting
2016 | Year | 04 | Month | 09 | Day |
2016 | Year | 04 | Month | 09 | Day |
2018 | Year | 12 | Month | 31 | Day |
None
2016 | Year | 04 | Month | 09 | Day |
2017 | Year | 10 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025094
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