UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026021 |
|---|---|
| Receipt number | R000029902 |
| Scientific Title | Comparison between Optimal Coherence tomography guidance and Angiography Guidance in percutaneous coronary intervention |
| Date of disclosure of the study information | 2017/02/06 |
| Last modified on | 2023/02/13 08:40:27 |
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Basic information
Public title
Comparison between Optimal Coherence tomography guidance and Angiography Guidance in percutaneous coronary intervention
Acronym
COCOA study
Scientific Title
Comparison between Optimal Coherence tomography guidance and Angiography Guidance in percutaneous coronary intervention
Scientific Title:Acronym
COCOA study
Region
| Japan |
Condition
Condition
Ischemic Heart Disease,percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the percutaneous coronary intervention (PCI) using the second generation drug eluting stent, the effectiveness of optical coherence tomography (OCT) guidance is compared with coronary angiography guidance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Minimum Stent Area (MSA) after PCI implementation by OCT evaluation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PCI with standard coronary angiography guide
Interventions/Control_2
PCI with Optical coherence tomography (OCT) guidance
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) patients with stable angina pectoris or unstable angina pectoris or non-ST elevation type acute myocardial infarction patients (judged based on the guidelines) having a PCI adaptation new lesion in the coronary artery using a drug eluting stent
2) Patients who aged 20 years or older at the time of acquisition
3) Patients who gained written consent by the patient
Key exclusion criteria
1) Patients with ST elevation myocardial infarction(STEMI)
2) Hemodynamic supplements or vasopressors with cardiogenic shock (defined as persistent hypotension with systolic blood pressure <90mm/Hg persisting for more than 30 minutes) or pressure rising/intra-aortic balloon pumping at the time of the procedure Required patient
3) Heart failure patients
4) Patients with three branches disease
5) Patients planned to use bare metal stent (BMS)
6) Patients with renal dysfunction (eGFR 30ml/min/1.73m2 or less or serum creatinine 1.5mg/dl or more)
7) Patients during dialysis treatment
8) Patients who are known to have allergies to aspirin, clopidogrel, prasugrel, heparin, iodine contrast medium,
9) Patients with hemorrhagic complications such as intracranial hemorrhage and gastrointestinal bleeding
10) Patients planning surgical treatment with in 12month after PCI
11) Patients with one or more co-morbidities that shorten life expectancy to less than 12 months or that may interfere with the study process according to this study protocol
12) Patients participating in clinical trials of other medical devices and drugs and judged by the attending physician as affecting the main endpoint of this study
13) Patients scheduled to use IVUS for the PCI to be tested
14) Patients whose treatment subject lesion morphology falls under any of the following
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Akasaa |
Organization
Wakayama Medical University
Division name
Cardiovascular Division
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama city, Wakayama pref, Japan
TEL
073-441-0621
akasat@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Minagawa |
Organization
CV quest Co., Ltd.
Division name
Clinical Research Support Division
Zip code
107-0062
Address
6-13-9 3B, Minami-aoyama, Minato, Tokyo, Japan
TEL
03-6427-9947
Homepage URL
cocoa@cvq.co.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO Co., Ltd.
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
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama city, Wakayama pref, Japan
Tel
073-441-0621
kubo.takashi@yahoo.com
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
| 2017 | Year | 02 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029902
| Research Plan | |
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| Registered date | File name |
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