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

The present study aims to demonstrate the superiority of optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) compared with Angiography-guided PCI.

Study Overview

• Status: Unknown
• Conditions: Coronary Disease
• Intervention / Treatment: Device: OCT; Device: Angiography

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).

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Wakayama, Japan, 6418509
    • Department of Cardiovascular Medicine, Wakayama Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum stent area	Minimum stent area is measured by OCT	Immediately after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel failure	Target vessel failure is defined as a composite of cardiac death, target-vessel related myocardial infarction, and ischaemia-driven target vessel revascularisation	12-month afte PCI

Collaborators and Investigators

• Sponsor: Takashi Kubo, MD
• Collaborators: Daiichi Sankyo, Inc.
• Investigators: Principal Investigator: Takashi Akaska, MD, Wakayama Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; optical coherence tomography
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: 1856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No