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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Cordis Corporation.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Cordis Corporation Identifier:
First received: November 20, 2006
Last updated: February 7, 2014
Last verified: February 2014
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:

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 ]

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 ]
  • 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 ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00403078

Contact: Clinical Trial Triage 877-820-TRIAL
Contact: Amy Orlick 908-541-4347

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
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

Responsible Party: Cordis Corporation Identifier: NCT00403078     History of Changes
Other Study ID Numbers: P06-3603
Study First Received: November 20, 2006
Last Updated: February 7, 2014

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 processed this record on September 20, 2017