UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021844 |
|---|---|
| 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 |
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Basic information
Public 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-
Acronym
IGNITE study
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-
Scientific Title:Acronym
IGNITE study
Region
| Japan |
Condition
Condition
Symptomatic peripheral artery disease:
-Moderate or severe claudication (Rutherford category 2 or 3)
-Critical limb ischemia (Rutherford category 4 or 5)
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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
Key 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%)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Fujihara |
Organization
Kishiwada Tokushukai Hospital
Division name
Cardiology
Zip code
Address
4-27-1 Kamoricho Kishiwada
TEL
072(445)9915
masahiko-fujihara@themis.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Fujihara |
Organization
Kishiwada Tokushukai Hospital
Division name
Cardiology
Zip code
Address
4-27-1 Kamoricho Kishiwada
TEL
072(445)9915
Homepage URL
masahiko-fujihara@themis.ocn.ne.jp
Sponsor or person
Institute
Japan Endovascular Treatment Conference
Institute
Department
Personal name
Funding Source
Organization
Japan Endovascular Treatment Conference
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025094
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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