Status:
TEMPORARILY_NOT_AVAILABLE
Complete Lesion Versus Culprit Lesion Revascularization
Lead Sponsor:
Korea University Guro Hospital
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
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...
Detailed Description
Acute ST segment elevation myocardial infarctions (STEMI) is a systemic prothrombotic milieu, often involves more than one coronary artery, even though it predominantly affects plaque rupture and its ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01180218
Last Update
August 14 2019
Active Locations (1)
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1
Seung Woon Rha
Seoul, South Korea