UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041264 |
|---|---|
| Receipt number | R000047090 |
| Scientific Title | Impact of Hinge Motion on Stent Edge-related Restenosis after Right Coronary Artery Treatment in the Current Drug-Eluting Stent Era |
| Date of disclosure of the study information | 2020/07/31 |
| Last modified on | 2020/07/30 22:36:21 |
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Basic information
Public title
Impact of Hinge Motion on Stent Edge-related Restenosis after Right Coronary Artery Treatment in the Current Drug-Eluting Stent Era
Acronym
Hinge Motion and Stent Edge-related Restenosis
Scientific Title
Impact of Hinge Motion on Stent Edge-related Restenosis after Right Coronary Artery Treatment in the Current Drug-Eluting Stent Era
Scientific Title:Acronym
Hinge Motion and Stent Edge-related Restenosis
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between hinge motion after coronary stent implantation and stent edge related restenosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stent edge-related restenosis at follow-up coronary angiography
Key secondary outcomes
Target lesion revascularization, target vessel myocardial infarction
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were performed percutaneous coronary intervention for right coronary artery with drug eluting stents after 2nd generation from March 2009 to March 2019 at NTT medical center Tokyo
Key exclusion criteria
Patients without follow-up coronary angiography
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Jimba |
Organization
NTT Medical Center Tokyo
Division name
Division of cardiology
Zip code
1410022
Address
5-9-22 Higashigotanda Shinagawa Tokyo Japan
TEL
03-3448-6111
blackjtaka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Jimba |
Organization
NTT Medical Center Tokyo
Division name
Division of cardiology
Zip code
1410022
Address
5-9-22 Higashigotanda Shinagawa Tokyo Japan
TEL
03-3448-6111
Homepage URL
blackjtaka@yahoo.co.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
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
NTT Medical Center Tokyo
Address
5-9-22 Higashigotanda Shinagawa Tokyo Japan
Tel
03-3448-6111
blackjtaka@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 31 | 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
391
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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Angiographies of included patients at post-stent and follow-up were retrospectively analyzed. In addition, patient background and clinical outcome were obtained from outpatient records.
Management information
Registered date
| 2020 | Year | 07 | Month | 30 | Day |
Last modified on
| 2020 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047090
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| Registered date | File name |
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| Registered date | File name |
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