Status:
UNKNOWN
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ba...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00192868
Start Date
May 1 2005
End Date
November 1 2011
Last Update
September 23 2009
Active Locations (1)
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1
Cardiac Cath Lab, Rigshospitalet
Copenhagen, Denmark, DK-2100