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)
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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