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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041264
Receipt No. 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

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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
Email 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
Email blackjtaka@yahoo.co.jp

Sponsor
Institute NTT Medical Center Tokyo
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047090

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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