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Status:

COMPLETED

Femoral Versus Radial Access for Primary PCI

Lead Sponsor:

Ottawa Heart Institute Research Corporation

Conditions:

Myocardial Infarction

STEMI

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Primary percutaneous coronary intervention (PPCI) has become the dominant strategy for the treatment of ST-elevation myocardial infarction (STEMI), as studies have shown that PPCI is superior to fibri...

Eligibility Criteria

Inclusion

  • Ischemic chest discomfort of greater or equal to 30 minutes duration,
  • Onset of chest pain of greater or equal to 12 hrs prior to entry into the study,
  • ST segment elevation of \> 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old

Exclusion

  • Age \< 18 yrs
  • Active bleeding
  • Inadequate vascular access from the femoral arteries (i.e. severe peripheral vascular artery disease precluding right or left femoral approach)
  • Abnormal Allen's test precluding either right or left radial approach
  • PCI within the last 30 days
  • Fibrinolytic agents within the last 7 days
  • Warfarin, dabigatran or other oral anticoagulant within the last 7 days
  • Known coagulation disorder (i.e. INR \>2.0, platelets \<100,000 / mm3)
  • Allergy to aspirin
  • Participation in a study with another investigational device or drug \< four weeks
  • Known severe renal impairment (creatinine \>200 umol/L)\*
  • Known severe contrast (dye) allergy
  • Prior coronary artery bypass surgery
  • Inability to provide informed consent
  • Bivalirudin is contraindicated in renal failure.

Key Trial Info

Start Date :

July 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 16 2019

Estimated Enrollment :

2292 Patients enrolled

Trial Details

Trial ID

NCT01398254

Start Date

July 1 2011

End Date

January 16 2019

Last Update

January 29 2019

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

St. Boniface Hospital

Winnipeg, Manitoba, Canada, R2H 2A6

2

Saint John Regional Hospital

Saint John, New Brunswick, Canada, E2L 4L2

3

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada, B3H 4G4

4

University of Ottawa Heart Institute

Ottawa, Ontario, Canada, K1Y 4W7