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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033009
Receipt No. 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 2019/07/05

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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
Email 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
Email sotomiyohei@gmail.com

Sponsor
Institute Department of Cardiology, Osaka Police Hospital
Institute
Department

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
Email 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 Open public recruiting
Date of protocol fixation
2016 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 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 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
2019 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037582

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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