SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

Tracking Information
First Submitted Date	November 20, 2006
First Posted Date	November 23, 2006
Last Update Posted Date	February 10, 2014
Study Start Date	October 2006
Estimated Primary Completion Date	July 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: April 29, 2010)	Any death, stroke or any MI [ Time Frame: up to 30-days post-procedure ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00403078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: August 2, 2012)	Assess the consistency of MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease among high, medium and low volume centers with physicians who have validated CASES training levels of 1, 2, 2P or 3 [ Time Frame: 30 days ]; Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled [ Time Frame: Every follow-up where a PRO instrument QoL was assessed ]; Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment [ Time Frame: 1 year ]
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
Official Title	Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
Brief Summary	The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease. The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
Detailed Description	Carotid Artery Stenting
Study Type	Observational
Study Design	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies) from up to 350 clinical sites in the US and Canada.
Condition	Carotid Artery Disease
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Massop D, Dave R, Metzger C, Bachinsky W, Solis M, Shah R, Schultz G, Schreiber T, Ashchi M, Hibbard R; SAPPHIRE Worldwide Investigators. Stenting and angioplasty with protection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry first 2,001 patients. Catheter Cardiovasc Interv. 2009 Feb 1;73(2):129-36. doi: 10.1002/ccd.21844.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: August 2, 2012)	21000
Original Enrollment; (submitted: November 22, 2006)	10000
Estimated Study Completion Date	November 2014
Estimated Primary Completion Date	July 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: High-surgical risk patients to be treated consistent with IFU labeling; The patient or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee. Exclusion Criteria: Patients not treated per the IFU; Patients who are contraindicated per the IFU; Patients previously enrolled in the study; Patients requiring stenting of in-stent restenosis after CAS; Inability or refusal to provide informed consent.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00403078
Other Study ID Numbers	P06-3603
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Cordis Corporation
Study Sponsor	Cordis Corporation
Collaborators	Not Provided
Investigators	Principal Investigator: Rajesh Dave, MD Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110 Principal Investigator: Robert Hibbard, MD Bryan LGH Heart Institute, 1500 South 48th St, Suite 400, Lincoln, NE 68506 Principal Investigator: Douglas Massop, MD Iowa Clinic-Heart and Vascular Care, 5950 University Ave, West Des Moines, IA 50266 Principal Investigator: Christopher Metzger, MD The Heart Center, PC, 2050 Meadowview Parkway, Kingsport, TN 37660
PRS Account	Cordis Corporation
Verification Date	February 2014