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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006506
Receipt No. R000007718
Scientific Title Multicenter randomized comparison between fractional flow reserve guidance and intravascular ultrasound guidance for optimizing drug-eluting stent implantation
Date of disclosure of the study information 2011/11/01
Last modified on 2019/06/29

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Basic information
Public title Multicenter randomized comparison between fractional flow reserve guidance and intravascular ultrasound guidance for optimizing drug-eluting stent implantation
Acronym Comparison of FFR guidance and IVUS guidance for optimizing DES
Scientific Title Multicenter randomized comparison between fractional flow reserve guidance and intravascular ultrasound guidance for optimizing drug-eluting stent implantation
Scientific Title:Acronym Comparison of FFR guidance and IVUS guidance for optimizing DES
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of FFR guidance in comparison with IVUS guidance for optimizing drug-eluting stent implantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cardiac death, myocardial infarction, and target lesion revascularization after 1 year
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Fractional flow reserve (FFR)
Interventions/Control_2 Intravascular ultrasound (IVUS)
Interventions/Control_3 Promus stent
Interventions/Control_4 Nobori stent
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are going to perform PCI using drug-eluting stents
Key exclusion criteria no exclusion criteria in this study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Shinjo
Middle name
Last name Sonoda
Organization University of Occupational and Environmental Health
Division name Department of Cardiovascular Medicine
Zip code 807-8555
Address 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka
TEL 093-691-7250
Email sonoda-sgy@umin.net

Public contact
Name of contact person
1st name Shinjo
Middle name
Last name Sonoda
Organization University of Occupational and Environmental Health
Division name Department of Cardiovascular Medicine
Zip code 807-8555
Address 1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka
TEL 0936917250
Homepage URL
Email sonoda-sgy@umin.net

Sponsor
Institute The 2nd Department of Internal Medicine, University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB in UOEH
Address 1-1, Iseigaoka, Yahatanishiku, Kitakyushu
Tel 093-603-7205
Email j-gairon@mbox.med.uoeh-u.ac.jp

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 産業医科大学病院、福岡大学病院、小倉記念病院、福岡済生会病院(いずれも福岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 01 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 250
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 No longer recruiting
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
2011 Year 04 Month 20 Day
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2019 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 08 Day
Last modified on
2019 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007718

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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