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Complete Lesion Versus Culprit Lesion Revascularization (COCUA)

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. Identifier: NCT01180218
Expanded Access Status : Temporarily not available
First Posted : August 12, 2010
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Seung Woon Rha, Korea University Guro Hospital

Brief Summary:
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 or disease Intervention/treatment
Myocardial Infarction Procedure: complete revascularization Procedure: Culprit revasularization

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Study Type : 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 the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT01180218

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Korea, Republic of
Seung Woon Rha
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University Guro Hospital
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Principal Investigator: Seung Woon Rha professor
Publications of Results:
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Responsible Party: Seung Woon Rha, Associate professor, Korea University Guro Hospital Identifier: NCT01180218    
Other Study ID Numbers: KoreaUGuroH_1
First Posted: August 12, 2010    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Seung Woon Rha, Korea University Guro Hospital:
myocardial revascularization
myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases