Status:
TERMINATED
SAFE-PCI for Women
Lead Sponsor:
Duke University
Collaborating Sponsors:
American College of Cardiology
Abbott Medical Devices
Conditions:
Percutaneous Coronary Intervention
Ischemic Symptoms
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI, transradial PCI will result in a significant reduction in bleeding and vascular complications. The primary objec...
Eligibility Criteria
Inclusion
- Have the capacity to understand and sign an informed consent form
- Age ≥ 18 years
- Female patient undergoing urgent or elective PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI
Exclusion
- Peripheral arterial disease that prohibits vascular access
- Bilateral abnormal Barbeau tests
- Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (note that the opposite arm may be used for radial access in case a dialysis graft is present in one arm provided that the opposite arm has a normal Barbeau test)
- International normalized ratio (INR) ≥ 1.5 in a patient treated with oral vitamin K antagonists (i.e., warfarin).
- Receipt of oral Factor Xa or IIa inhibitors ≤ 24 hours prior to the procedure
- Planned staged PCI within 30 days of index procedure
- Valvular heart disease requiring valve surgery
- Planned right-heart catheterization
- Primary PCI for ST-segment elevation myocardial infarction
- Presence of bilateral internal mammary artery coronary bypass grafts
- Unable to provide informed consent
- Participation in any investigational drug or device study currently or within 30 days prior to enrollment
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
1787 Patients enrolled
Trial Details
Trial ID
NCT01406236
Start Date
August 1 2011
End Date
September 1 2013
Last Update
January 21 2015
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