Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction

Rigshospitalet

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Procedure: Distal protection and drug eluting stent

Study type

Interventional

Funder types

Other

Identifiers

NCT00192868

DEDICATION

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute onset typical chest pain of < 12 hours' duration
ST-elevation of > 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram
High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire
Possibility to perform distal protection of the infarct-related artery

Exclusion criteria

History of previous myocardial infarction
Use of fibrinolytic agents for the index infarction
Left main stenosis
Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route
Known renal failure
Other significant cardiac disease
Other severe disease with an expected survival < 1 year
Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication
Linguistic difficulties needing an interpreter
Gastrointestinal bleeding within 1 month
Childbearing potential or pregnancy
Participation in another study