Complete Lesion Versus Culprit Lesion Revascularization (COCUA)

Expanded access is currently available for this treatment.
Verified October 2015 by Korea University Guro Hospital
Information provided by (Responsible Party):
Seung Woon Rha, Korea University Guro Hospital Identifier:
First received: August 10, 2010
Last updated: October 20, 2015
Last verified: October 2015
To investigate the clinical outcomes of acute myocardial infarction (AMI) patients with multivessel disease undergoing percutaneous coronary intervention (PCI) either in infarct-related artery only or in multivessel in Drug eluting stents (DES) era, using the everolimus-eluting stent (Promus™ Element™ Stent, Boston Scientific) in real-world clinical practice.

Condition Intervention Phase
Myocardial Infarction
Procedure: complete revascularization
Procedure: Culprit revasularization
Phase 4

Study Type: Expanded Access     What is Expanded Access?
Official Title: Comparison of Complete Lesion Versus Culprit Lesion Revascularization in Acute ST Elevation Myocardial Infarction Patients With Multivessel Disease Undergoing Primary Percutaneous Coronary Intervention

Resource links provided by NLM:

Further study details as provided by Korea University Guro Hospital:

Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: complete revascularization
    -Complete revascularization : one time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions in patient with ST elevateion myocardial infarction (STEMI) and multivessle disease
    Procedure: Culprit revasularization
    Culprit revascularization : PCI of only the culprit lesion and staged nonculprit PCI at a later date in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease.
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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject must be at least 18 years of age.
  • Subject is able to verbally confirm understandings of risks, benefits and treatment of culprit or complete revascularization using everolimus eluting coronary stent (Promus™ Element™ Stent) and he or she or his or her legally authorized representative provides written informed consent prior to any study related procedure.
  • Subject must have significant more than two target lesions and requiring primary PCI for acute ST elevation myocardial infarction (STEMI) within 48hrs
  • Target lesion(s) must be located in a native coronary artery with visually estimated diameter of less than 2.5 mm and more than 4.0 mm.
  • Target lesion(s) must be amenable for percutaneous coronary intervention

Exclusion Criteria:

  • The patient has a known hypersensitivity or contraindication to any of the following medications:

Heparin Aspirin Both Clopidogrel and Ticlopidine Everolimus Platinum chromium Contrast media

  • Patients with documented sensitivity to contrast media which can be effectively pre medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.
  • Systemic (intravenous) everolimus use within 12 months. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  • History of bleeding diathesis or known coagulopathy (including heparin- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months,induced thrombocytopenia), or will refuse blood transfusions.
  • An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
  • Non-cardiac comorbid conditions are present with life expectancy over 1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • Patients with more than 25 percentage of LVEF or those with cardiogenic shock
  • Creatinine level more than 3mg per dL or dependence on dialysis.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01180218

Contact: Seung Woon Rha 82-2-2626-3020
Contact: Ji Young Park 82-2-970-8620

Korea, Republic of
Seung Woon Rha
Seoul, Korea, Republic of
Contact: Seung Woon Rha, MD,PhD    82-2626-3020   
Principal Investigator: Seung Woon Rha, MD,PhD         
Sponsors and Collaborators
Korea University Guro Hospital
Principal Investigator: Seung Woon Rha professor
  More Information

Responsible Party: Seung Woon Rha, Associate professor, Korea University Guro Hospital Identifier: NCT01180218     History of Changes
Other Study ID Numbers: KoreaUGuroH_1
Study First Received: August 10, 2010
Last Updated: October 20, 2015
Health Authority: Korea: Institutional Review Board

Keywords provided by Korea University Guro Hospital:
myocardial revascularization
myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases processed this record on November 27, 2015