UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026021
Receipt No. 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 2017/02/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Takashi Akasaka
Organization Wakayama Medical University
Division name Cardiovascular Division
Zip code
Address 811-1, Kimiidera, Wakayama city, Wakayama pref, Japan
TEL 073-441-0621
Email akasat@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Minagawa
Organization CV quest Co., Ltd.
Division name Clinical Research Support Division
Zip code
Address 6-13-9 3B, Minami-aoyama, Minato, Tokyo, Japan
TEL 03-6427-9947
Homepage URL
Email cocoa@cvq.co.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 13 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
2017 Year 02 Month 06 Day
Last modified on
2017 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029902

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.