We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison Between Optimal Coherence Tomography Guidance and Angiography Guidance in Percutaneous Coronary Intervention (COCOA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176810
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Kubo Takashi, Wakayama Medical University
  Purpose
The present study aims to demonstrate the superiority of optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) compared with Angiography-guided PCI.

Condition Intervention
Coronary Disease Device: OCT Device: Angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Comparison Between Optimal Coherence Tomography Guidance and Angiography Guidance in Percutaneous Coronary Intervention

Further study details as provided by Kubo Takashi, Wakayama Medical University:

Primary Outcome Measures:
  • Minimum stent area [ Time Frame: Immediately after PCI ]
    Minimum stent area is measured by OCT


Secondary Outcome Measures:
  • Target vessel failure [ Time Frame: 12-month afte PCI ]
    Target vessel failure is defined as a composite of cardiac death, target-vessel related myocardial infarction, and ischaemia-driven target vessel revascularisation


Enrollment: 550
Actual Study Start Date: April 1, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OCT-guided PCI
PCI is performed by OCT guidance.
Device: OCT
OCT is used to guide PCI.
Active Comparator: Angiography-guided PCI
PCI is performed by angiography guidance alone.
Device: Angiography
Angiography is used to guide PCI.

Detailed Description:
Comparison between Optimal Coherence tomography guidance and Angiography Guidance in percutaneous coronary intervention (COCOA) is a prospective, multicentre, randomised, open-label, parallel group, active-controlled, superiority trial comparing minimum stent area immediately after optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with those after Angiography-guided PCI with a second generation drug-eluting stent.The primary endpoint of the present study was minimum stent area immediately after PCI. The secondary endpoint was target vessel failure (defined as a composite of cardiac death, target-vessel related myocardial infarction, and ischaemia-driven target vessel revascularisation).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients eligible for PCI using drug-eluting stent (DES) to a de novo native coronary artery lesion in stable angina pectoris, unstable angina pectoris or non-ST-segment elevation myocardial infarction (evaluated based on the guideline)
  2. Aged 20 years or older at the time of their consent
  3. Patients who agree to be enrolled in the trial giving signed written informed consent

Exclusion Criteria:

1) Patients who have showed ST-segment elevation myocardial infarction in previous 3 months 2) Patients with cardiogenic shock 3) Patients with heart failure 4) Patients with 3-vessel disease 5) Patients scheduled to use bare metal stent 6) Patients with renal function disorder (eGFR 30 mL/min/1.73 m2 or less or serum creatinine 1.5 mg/dL or more) 7) Patients undergoing hemodialysis 8) Patients with allergies to aspirin, clopidogrel, prasugrel, heparin, and iodinated contrast agents 9) Patients with hemorrhagic complications such as intracranial hemorrhage and gastrointestinal bleeding 10) Patients scheduled to undergo surgical treatment after PCI within 1 year 11) Patients participating in the clinical study of other medical device or drug and who were considered affecting the primary endpoint of this study by the physician in charge 12) 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 13) Patients scheduled to use IVUS in PCI 14) Patients in whom the form of the target disease concerned is applicable to any of the following lesions: (i) Lesion in the previously (within 1 year) treated coronary artery or lesion in the coronary artery with the other lesions requiring revascularization with PCI in the near future (within 1 year) (ii) Lesion in the left main coronary artery (iii) Lesion in the coronary bypass graft (iv) Aorto-ostial lesion in right coronary artery (arising within 3 mm of the origin of a right coronary artery) (v) Lesion of chronic total occlusion (vi) Coronary bifurcation lesion requiring revascularization with 2 stents (vii) Coronary bypass graft lesion (viii) Lesion in coronary artery with diameter of < 2.5mm or >4.00mm (ix) Long lesion (length >40mm) (x) Lesion in coronary artery where we expected difficulty in advancing the OCT catheter (e.g. extremely tortuous artery or severely calcified artery)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176810


Locations
Japan
Department of Cardiovascular Medicine, Wakayama Medical University
Wakayama, Japan, 6418509
Sponsors and Collaborators
Kubo Takashi
Daiichi Sankyo, Inc.
Investigators
Principal Investigator: Takashi Akaska, MD Wakayama Medical University
  More Information

Responsible Party: Kubo Takashi, Associate Professor, Wakayama Medical University
ClinicalTrials.gov Identifier: NCT03176810     History of Changes
Other Study ID Numbers: 1856
First Submitted: June 1, 2017
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kubo Takashi, Wakayama Medical University:
percutaneous coronary intervention
optical coherence tomography

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases