UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033009 |
|---|---|
| Receipt number | R000037582 |
| Scientific Title | EaRly and long-tErm veSsel healing afTer implantatiOn of duRable polymer DES and bioabsorbable polymer DES: imaging analysis by OCT and coronary angioscopy (RESTORE registry) |
| Date of disclosure of the study information | 2018/06/15 |
| Last modified on | 2023/12/18 13:42:49 |
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Basic information
Public title
EaRly and long-tErm veSsel healing afTer implantatiOn of duRable polymer DES and bioabsorbable polymer DES: imaging analysis by OCT and coronary angioscopy (RESTORE registry)
Acronym
RESTORE registry
Scientific Title
EaRly and long-tErm veSsel healing afTer implantatiOn of duRable polymer DES and bioabsorbable polymer DES: imaging analysis by OCT and coronary angioscopy (RESTORE registry)
Scientific Title:Acronym
RESTORE registry
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to investigate the difference in the vessel healing quality between bioresorbable polymer DES and durable polymer DES.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
1. Neointimal coverage grade on coronary angioscopy 3 and 24 months after stent implantation
2. Light property on optical coherence tomography 3 and 24 months after 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Any PCI indication for native coronary lesions satisfying the following criteria
1. PCI indication for any clinical presentation including stable and unstable angina, silent myocardial ischemia, non-ST elevation and ST elevation myocardial infarction.
2. Subject is appropriate to be treated by PCI according to the local practice.
3. Patient is at least 20 years of age.
4. Signed informed consent.
5. The patient understands and accepts clinical follow-up.
Angiographic:
1. Patients with angiographically significant stenosis in de novo, native, previously unstinted lesions, which is in operator's opinion appropriate to be treated by PCI.
2.Significant stenosis was defined as 90% or greater stenosis of a major epicardial vessel or proof of functional ischemic test.
3. Patients with angiographically significant stenosis, which is in operator's opinion related to symptoms of angina.
Key exclusion criteria
1. Known hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, cobalt chromium, platinum chromium, everolimus, sirolimus, or a sensitivity to contrast media, which cannot be adequately pre-medicated
2. Participation in another clinical trial (up to 12 months after index procedure)
3. Patients with a life expectancy of < 2 year
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Police Hospital
Division name
Department of Cardiology
Zip code
543-0035
Address
10-31, Kitayama, Tennoji, Osaka, Japan
TEL
0667716051
yhiguchi-ja@umin.net
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sotomi |
Organization
Osaka Police Hospital
Division name
Department of Cardiology
Zip code
543-0035
Address
10-31, Kitayama, Tennoji, Osaka, Japan
TEL
0667716051
Homepage URL
sotomiyohei@gmail.com
Sponsor or person
Institute
Department of Cardiology, Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
IRB, Osaka Police Hospital
Address
10-31, Kitayama, Tennoji, Osaka, Japan
Tel
0667716051
yhiguchi-ja@umin.net
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 | 06 | Month | 15 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PCI will be performed with durable polymer stent and bioresorbable polymer stent under the guidance of intravascular ultrasound (IVUS) or optical coherence tomography (OCT).
Treatment strategies including pre-dilatation, atherectomy, post-dilatation, etc. will be left to the operators' discretion.
Imaging and clinical follow-up at 3 months and 24 months after stent implantation is planned.
Management information
Registered date
| 2018 | Year | 06 | Month | 15 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037582
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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