UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030732 |
|---|---|
| Receipt number | R000035094 |
| Scientific Title | Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting Stent Trial: Extended Follow-up Study |
| Date of disclosure of the study information | 2018/02/02 |
| Last modified on | 2018/01/09 13:26:04 |
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Basic information
Public title
Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting Stent Trial:
Extended Follow-up Study
Acronym
RESET:Extended Follow-up Study
Scientific Title
Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting Stent Trial:
Extended Follow-up Study
Scientific Title:Acronym
RESET:Extended Follow-up Study
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term efficacy and safety of cobalt chrome everolimus-eluting stent (CoCr-EES) of XIENCE V and 1st generation sirolimus-eluting stent (SES) of Cypher
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Any TLR
A composite of all-cause death and MI
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
3196 patients who participated in the RESET trial.
Key exclusion criteria
Patients who refuse to participate.
Target sample size
3196
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4255
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Shiomi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4255
Homepage URL
hishiomi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Research Institute for Production Development
Institute
Department
Personal name
Funding Source
Organization
Abbott Vascular
Organization
Division
Category of Funding Organization
Profit organization
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
| 2018 | Year | 02 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is the extended follow-up study of the RESET randomized study.
Management information
Registered date
| 2018 | Year | 01 | Month | 09 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035094
