UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021844
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email masahiko-fujihara@themis.ocn.ne.jp

Sponsor
Institute Japan Endovascular Treatment Conference
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025094

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.