UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013571 |
|---|---|
| Receipt number | R000015723 |
| Scientific Title | Observational study of efficacy and safety after everolimus-eluting stent implantation; Tokyo-MD PCI study |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2014/03/31 10:00:58 |
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Basic information
Public title
Observational study of efficacy and safety after everolimus-eluting stent implantation; Tokyo-MD PCI study
Acronym
Observational study of everolimus-eluting stent implantation; Tokyo-MD PCI study
Scientific Title
Observational study of efficacy and safety after everolimus-eluting stent implantation; Tokyo-MD PCI study
Scientific Title:Acronym
Observational study of everolimus-eluting stent implantation; Tokyo-MD PCI study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the efficacy and safety of everolimus-eluting stent implantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical events and prognosis after everolimus-eluting stent implantation
Key secondary outcomes
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
all patients
Key exclusion criteria
no exclusion criteria
Target sample size
1077
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Isobe |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-5-45 Yushima Bunkyoku Tokyo Japan
TEL
81-3-5803-5951
isobemi.cvm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Yoshikawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-5-45 Yushima Bunkyoku Tokyo Japan
TEL
81-3-5803-5951
Homepage URL
sysh.cvm@tmd.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Tokyo Medical and Dental University
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
Address
Tel
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
| 2014 | Year | 04 | 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
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
| 2012 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data from patients undergoing everolimus-eluting stent implantation at 22 institutions between February 2010 and December 2011 were collected. Adverse events were tabulated for 4 years after everolimus-eluting implantation.
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2014 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015723
