SAFE-PCI for Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American College of Cardiology Foundation
Abbott Vascular
Lilly USA
Medtronic
Terumo Medical Corporation
The Medicines Company
Acist Medical Systems
Guerbet
FDA - Office of Women's Health
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01406236
First received: June 20, 2011
Last updated: August 27, 2013
Last verified: August 2013

June 20, 2011
August 27, 2013
August 2011
September 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Primary Efficacy Endpoint: Composite of BARC Types 2, 3, and 5 bleeding or vascular complications. [ Time Frame: Within 72 hours post-procedure 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: Within 72 hours post-procedure or hospital discharge, whichever occurs first. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01406236 on ClinicalTrials.gov Archive Site
  • Procedure Duration, total radiation dose and total contrast volume [ Time Frame: 72 hours post randomization or hospital discharge (whichever occurs first) ] [ Designated as safety issue: No ]
    To determine the effect of transradial PCI on procedure time, total radiation dose, and total contrast volume.
  • Resource Use, patient preferences and quality of life [ Time Frame: Baseline, 72 hours post randomization or hospital discharge (whichever occurs first), 30 day ] [ Designated as safety issue: No ]
    To determine the effect of transradial PCI on resource use, patient preferences, and quality of life.
  • 30-day death, vascular complications, or repeat revascularization [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    To determine the effect of transradial PCI on 30-day death, vascular complications, or repeat revascularization.
Not Provided
Not Provided
Not Provided
 
SAFE-PCI for Women
Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Percutaneous Coronary Intervention
  • Ischemic Symptoms
  • Procedure: Transradial PCI
    Transradial PCI
  • Procedure: Transfemoral PCI
    Transfemoral PCI
  • Transradial PCI
    Intervention: Procedure: Transradial PCI
  • Transfemoral PCI
    Intervention: Procedure: Transfemoral PCI
Hess CN, Rao SV, Kong DF, Aberle LH, Anstrom KJ, Gibson CM, Gilchrist IC, Jacobs AK, Jolly SS, Mehran R, Messenger JC, Newby LK, Waksman R, Krucoff MW. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am Heart J. 2013 Sep;166(3):421-8. doi: 10.1016/j.ahj.2013.06.013. Epub 2013 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3000
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01406236
Pro00030109
Yes
Duke University
Duke University
  • American College of Cardiology Foundation
  • Abbott Vascular
  • Lilly USA
  • Medtronic
  • Terumo Medical Corporation
  • The Medicines Company
  • Acist Medical Systems
  • Guerbet
  • FDA - Office of Women's Health
Principal Investigator: Sunil V Rao, MD Duke University
Duke University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP