SAFE-PCI for Women

This study is enrolling participants by invitation only.

Sponsor:

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: October 4, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 20, 2011

Last Updated Date

October 4, 2011

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01406236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

SAFE-PCI for Women

Official Title ^ICMJE

Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)

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 approximately 40 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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Percutaneous Coronary Intervention
Ischemic Symptoms

Intervention ^ICMJE

Procedure: Transradial PCI
Transradial PCI
Procedure: Transfemoral PCI
Transfemoral PCI

Study Arm (s)

Transradial PCI
Intervention: Procedure: Transradial PCI
Transfemoral PCI
Intervention: Procedure: Transfemoral PCI

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

3000

Estimated Completion Date

January 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 (see Section 8.2)
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
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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT01406236

Other Study ID Numbers ^ICMJE

Pro00030109

Has Data Monitoring Committee

Yes

Responsible Party

Duke University

Study Sponsor ^ICMJE

Duke University

Collaborators ^ICMJE

American College of Cardiology Foundation, Abbott Vascular, Lilly USA, Medtronic, Terumo Medical Corporation, The Medicines Company

Investigators ^ICMJE

Principal Investigator:

Sunil V Rao, MD

Duke University

Information Provided By

Duke University

Verification Date

October 2011

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

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