Trial record 1 of 1 for: SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2014 by Cordis Corporation

Sponsor:

Information provided by (Responsible Party):

Cordis Corporation

ClinicalTrials.gov Identifier:

NCT00403078

First received: November 20, 2006

Last updated: February 7, 2014

Last verified: February 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

November 20, 2006

Last Updated Date

February 7, 2014

Start Date ^ICMJE

October 2006

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Any death, stroke or any MI [ Time Frame: up to 30-days post-procedure ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00403078 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Carotid Artery Disease

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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 ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

21000

Estimated Completion Date

November 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Clinical Trial Triage	877-820-TRIAL
Contact: Amy Orlick	908-541-4347	aorlick@its.jnj.com

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00403078

Other Study ID Numbers ^ICMJE

P06-3603

Has Data Monitoring Committee

Yes

Responsible Party

Cordis Corporation

Study Sponsor ^ICMJE

Cordis Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Cordis Corporation

Verification Date

February 2014

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

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