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

This study is currently recruiting participants.
Verified February 2013 by Cordis Corporation
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00403078
First received: November 20, 2006
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  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:

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 ]
  • 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 ]

Estimated Enrollment: 21000
Study Start Date: October 2006
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (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
  • Patients previously enrolled in the study
  • Patients requiring stenting of in-stent restenosis after CAS
  • 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:

Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00403078     History of Changes
Other Study ID Numbers: P06-3603
Study First Received: November 20, 2006
Last Updated: February 26, 2013
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 21, 2013