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

This study is currently recruiting participants.

Verified by Cordis Corporation, October 2009

First Received: November 20, 2006 Last Updated: October 16, 2009 History of Changes

Sponsor:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00403078

Purpose

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).

Condition	Phase
Carotid Artery Disease	Phase IV

Study Type:	Observational
Study Design:	Prospective
Official Title:	Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Carotid Artery Disease

Drug Information available for: Aluminum oxide

U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

The primary objective of this study is to assess 30-day outcomes of stenting [ Time Frame: 30-day outcomes post-procedure ] [ Designated as safety issue: Yes ]
(any death, stroke and MI)with distal protection in the treatment of obstructive carotid [ Time Frame: Up to 12 month ] [ Designated as safety issue: Yes ]
Artery disease in relation to 30-day outcomes in the SAPPHIRE and CASES trials. [ Time Frame: 30-day outcome ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	10000
Study Start Date:	October 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Carotid Artery Stenting

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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
Inability or refusal to provide informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403078

Contacts

Contact: Robert Gash

908-541-4264

rgash1@its.jnj.com

Locations

United States, Delaware
Christiana Care Health Services	Recruiting
Newark, Delaware, United States, 19713
Contact: Ashish Parikh, M.D. 302-733-2658
Principal Investigator: Ashish Parikh, M.D.
United States, Pennsylvania
Harrisburg Hospital	Recruiting
Harrisburg, Pennsylvania, United States, 17110
Contact: Rajesh Dave, MD 717-920-4400
Principal Investigator: Rajesh Dave, M.D.

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

Rajesh Dave, MD

Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110

More Information

Publications:

Massop D, Dave R, Metzger C, Bachinsky W, Solis M, Shah R, Schultz G, Schreiber T, Ashchi M, Hibbard R; on behalf of the 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. 2008 Oct 15; [Epub ahead of print]

Responsible Party:	Cordis ( Wayne Hutman, MD )
Study ID Numbers:	PO6-3606
Study First Received:	November 20, 2006
Last Updated:	October 16, 2009
ClinicalTrials.gov Identifier:	NCT00403078 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Cordis Corporation:

Carotid Artery Stenting (Endovascular)

Additional relevant MeSH terms:

Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Cardiovascular Diseases

Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 20, 2009