Complete Lesion Versus Culprit Lesion Revascularization

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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