UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006506 |
|---|---|
| Receipt number | 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 | 2019/12/29 09:57:47 |
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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
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
sonoda-sgy@umin.net
Sponsor or person
Institute
The 2nd Department of Internal Medicine, University of Occupational and Environmental Health
Institute
Department
Personal name
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
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
Main results already published
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
| 2019 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 16 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 08 | Day |
Last modified on
| 2019 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007718
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
