NCT01406236

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 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. The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our trial is very low, making it unlikely that there will be statistical power to show a difference between the randomized arms in the SAFE PCI for Women study using the BARC bleeding definition per protocol. Based on this statistical futility, the DSMB has recommended stopping enrollment. They also noted, however, that as this is not based on any safety issues, and since there are a variety of key secondary endpoints (contrast and radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB left it to the discretion of the Steering Committee to continue enrollment to meet sufficient power for these outcomes. On March 1, 2013, the Steering Committee met to discuss these issues and voted to continue enrollment until the planned sample size for the Quality of Life substudy was met (300 patients).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,787

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

June 20, 2011

Last Update Submit

January 16, 2015

Conditions

Percutaneous Coronary InterventionIschemic Symptoms

Keywords

Femaleurgent or elective percutaneous coronary interventionPCIdiagnostic angiography

Outcome Measures

Primary Outcomes (2)

  • Primary Efficacy Endpoint: Composite of BARC Types 2, 3, and 5 bleeding or vascular complications.

    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.

    From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first.

Secondary Outcomes (3)

  • Procedure Duration, total radiation dose and total contrast volume

    72 hours post randomization or hospital discharge (whichever occurs first)

  • Resource Use, patient preferences and quality of life

    Baseline, 72 hours post randomization or hospital discharge (whichever occurs first), 30 day

  • 30-day death, vascular complications, or repeat revascularization

    30 day

Study Arms (2)

Transradial PCI

OTHER
Procedure: Transradial PCI

Transfemoral PCI

OTHER
Procedure: Transfemoral PCI

Interventions

Transradial PCIPROCEDURE

Transradial PCI

Transradial PCI
Transfemoral PCIPROCEDURE

Transfemoral PCI

Transfemoral PCI

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Rymer JA, Kaltenbach LA, Kochar A, Hess CN, Gilchrist IC, Messenger JC, Harrington RA, Jolly SS, Jacobs AK, Abbott JD, Wojdyla DM, Krucoff MW, Rao SV. Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women. Circ Cardiovasc Interv. 2019 May;12(5):e007086. doi: 10.1161/CIRCINTERVENTIONS.118.007086.

    PMID: 31014090DERIVED

  • Rao SV, Hess CN, Barham B, Aberle LH, Anstrom KJ, Patel TB, Jorgensen JP, Mazzaferri EL Jr, Jolly SS, Jacobs A, Newby LK, Gibson CM, Kong DF, Mehran R, Waksman R, Gilchrist IC, McCourt BJ, Messenger JC, Peterson ED, Harrington RA, Krucoff MW. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. JACC Cardiovasc Interv. 2014 Aug;7(8):857-67. doi: 10.1016/j.jcin.2014.04.007.

    PMID: 25147030DERIVED

  • 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.

    PMID: 24016489DERIVED

Study Officials

  • Sunil V Rao, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2011

First Posted

August 1, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 21, 2015

Record last verified: 2015-01