This trial is active, not recruiting.

Conditions percutaneous coronary intervention, ischemic symptoms
Treatments transradial pci, transfemoral pci
Sponsor Duke University
Collaborator American College of Cardiology Foundation
Start date August 2011
End date September 2013
Trial size 3000 participants
Trial identifier NCT01406236, Pro00030109


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 objective is to compare the efficacy and feasibility of the transradial approach to percutaneous coronary intervention (PCI) in women compared with the transfemoral approach.

This study is a multicenter, randomized, open-label active controlled study. Three thousand women undergoing urgent or elective PCI from at least 50 centers will be randomized to either transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc PCI will be randomized before diagnostic angiography. A total of approximately 3000 women will be randomized to obtain a cohort of approximately 1800 patients undergoing PCI.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
transradial pci
Transradial PCI
transfemoral pci
Transfemoral PCI

Primary Outcomes

Primary Efficacy Endpoint: Composite of BARC Types 2, 3, and 5 bleeding or vascular complications.
time frame: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.
Primary Feasibility Endpoint: Procedural failure, defined as inability to complete the procedure from the assigned vascular access site.
time frame: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.

Secondary Outcomes

Procedure Duration, total radiation dose and total contrast volume
time frame: 72 hours post randomization or hospital discharge (whichever occurs first)
Resource Use, patient preferences and quality of life
time frame: Baseline, 72 hours post randomization or hospital discharge (whichever occurs first), 30 day
30-day death, vascular complications, or repeat revascularization
time frame: 30 day

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)
Principal investigator Sunil V Rao, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Duke University.