UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005038 |
|---|---|
| Receipt number | R000005991 |
| Scientific Title | RE-implantation of CYpher stent for Cypher in-Lesion restenosis |
| Date of disclosure of the study information | 2011/02/14 |
| Last modified on | 2011/08/17 11:12:04 |
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Basic information
Public title
RE-implantation of CYpher stent for Cypher in-Lesion restenosis
Acronym
RECYCLE trial
Scientific Title
RE-implantation of CYpher stent for Cypher in-Lesion restenosis
Scientific Title:Acronym
RECYCLE trial
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether SES re-implantation is superior to POBA for the treatment of SES restenosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
late loss at 8-month follow-up angiography
Key secondary outcomes
1) restenosis rate
2) Target lesion revasclurarization at 8-month, 12-month
3) Major adverse cardiac events at 8-month, 12-month
4) stent thrombosis at 8-month, 12-month
5) impact of restenotic pattern such as fracture, gap, and edge restenosis on late loss
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
POBA
Interventions/Control_2
SES
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 with SES restenosis
Key exclusion criteria
Post resuscitation
Cardiogenic shock
ST elevation myocardial infarction
Unprotected Left main didesease
Patients who cannot torelate anti-platelet therapy
Pregnancy or lactation
Patients who were enrolled in the other trials
Malignancy
No indication for PCI
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kengo Tanabe |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
Address
Kandaizumi-chyo 1, Chiyoda-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naomi Yamaguchi |
Organization
Coronary Intervention Trial & Evaluation (CITE) group
Division name
Department of Cardiology, Teikyo University
Zip code
Address
TEL
Homepage URL
n-yama@med.teikyo-u.ac.jp
Sponsor or person
Institute
Coronary Intervention Trial & Evaluation (CITE) group
Institute
Department
Personal name
Funding Source
Organization
Coronary Intervention Trial & Evaluation (CITE) group
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
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
| 2011 | Year | 02 | Month | 14 | 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
| 2008 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 06 | Day |
Last modified on
| 2011 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005991
| 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 |
