UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047967 |
|---|---|
| Receipt number | R000054682 |
| Scientific Title | Randomized comparison between with and without ELCA for Lesion of ISR |
| Date of disclosure of the study information | 2022/06/06 |
| Last modified on | 2024/05/24 13:54:35 |
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Basic information
Public title
Randomized comparison between with and without ELCA for Lesion of ISR
Acronym
REAL-ISR
Scientific Title
Randomized comparison between with and without ELCA for Lesion of ISR
Scientific Title:Acronym
REAL-ISR
Region
| Japan |
Condition
Condition
in-stent restenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the efficacy of ELCA for ISR
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of neointimal area after PCI
Key secondary outcomes
Clinical outcome
Target lesion revascularization, binary stenosis
OCT data
Acute gain, late lumen loss, MLA, MSA
Laboratory data
Change of LDL-chol
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the use of ELCA during PCI
Interventions/Control_2
conventional therapy
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. the patients with PCI for in-stent restenosis lesion
2. the patients who enable to perform OCT
Key exclusion criteria
Judged by the doctor in charge as unsuitable
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | masami |
| Middle name | |
| Last name | nishino |
Organization
Osaka Rosai Hospital
Division name
cardiology
Zip code
591-8025
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3561
mnishino@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Shodai |
| Middle name | |
| Last name | Kawanami |
Organization
Osaka Rosai Hospital
Division name
cardiology
Zip code
591-8025
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
TEL
072-252-3561
Homepage URL
junnai-hisho@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Rosai Hospital
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
Osaka Rosai Hospital
Address
3069-1 Nagasone-cho, Kita-ku, Sakai-shi, Osaka
Tel
072-252-3561
junnai-hisho@osakah.johas.go.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
| 2022 | Year | 06 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054682
