SAFE-PCI for Women
This study is enrolling participants by invitation only.
Sponsor:
Duke University
Collaborator:
American College of Cardiology Foundation, Abbott Vascular, Lilly USA, Medtronic, Terumo Medical Corporation, The Medicines Company
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01406236
First received: June 20, 2011
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Percutaneous Coronary Intervention Ischemic Symptoms |
Procedure: Transradial PCI Procedure: Transfemoral PCI |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women) |
Further study details as provided by Duke University:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Transradial PCI |
Procedure: Transradial PCI
Transradial PCI
|
| Transfemoral PCI |
Procedure: Transfemoral PCI
Transfemoral PCI
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406236
Sponsors and Collaborators
Duke University
American College of Cardiology Foundation, Abbott Vascular, Lilly USA, Medtronic, Terumo Medical Corporation, The Medicines Company
Investigators
| Principal Investigator: | Sunil V Rao, MD | Duke University |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01406236 History of Changes |
| Other Study ID Numbers: | Pro00030109 |
| Study First Received: | June 20, 2011 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Female urgent or elective percutaneous coronary intervention PCI diagnostic angiography |
ClinicalTrials.gov processed this record on May 23, 2013