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

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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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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