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

This study is currently recruiting participants.

Verified August 2011 by Cordis Corporation

First Received on November 20, 2006. Last Updated on August 5, 2011 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 4

Study Type:	Observational
Study Design:	Time Perspective: 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:

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

Secondary Outcome Measures:

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 ]
Evaluate the impact of peri-procedural events on the quality of life (QoL) in subjects enrolled [ Time Frame: Every follow-up where a 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 ]

Estimated Enrollment:	15000
Study Start Date:	October 2006
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	March 2012 (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: Clinical Trial Triage	877-820-TRIAL
Contact: Amy Orlick	908-541-4347	aorlick@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, Iowa
Iowa Clinic, Heart & Vascular Care	Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Douglas Massop, MD 515-875-9090
Principal Investigator: Douglas Massop, MD
United States, Nebraska
Bryan LGH Heart Institute	Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Robert Hibbard, MD 402-483-3333
Principal Investigator: Robert Hibbard, MD
United States, Pennsylvania
Harrisburg Hospital	Recruiting
Harrisburg, Pennsylvania, United States, 17110
Contact: Rajesh Dave, MD 717-920-4400
Principal Investigator: Rajesh Dave, M.D.
United States, Tennessee
The Heart Center, PC	Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Christopher Metzger, MD 423-230-5640
Principal Investigator: Christopher Metzger, MD

Sponsors and Collaborators

Cordis Corporation

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

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:	Hans-Peter Stoll, MD, Cordis
ClinicalTrials.gov Identifier:	NCT00403078 History of Changes
Other Study ID Numbers:	P06-3603
Study First Received:	November 20, 2006
Last Updated:	August 5, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Cordis Corporation:

Carotid Artery Stenting (Endovascular)

Additional relevant MeSH terms:

Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2012