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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00403078
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation

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).

Condition or disease
Carotid Artery Disease

Detailed Description:
Carotid Artery Stenting

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Study Type : Observational
Actual Enrollment : 21008 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
Study Start Date : October 2006
Actual Primary Completion Date : July 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Any death, stroke or any MI [ Time Frame: up to 30-days post-procedure ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00403078


Locations
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United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Iowa
Iowa Clinic, Heart & Vascular Care
West Des Moines, Iowa, United States, 50266
United States, Nebraska
Bryan LGH Heart Institute
Lincoln, Nebraska, United States, 68506
United States, Pennsylvania
Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17110
United States, Tennessee
The Heart Center, PC
Kingsport, Tennessee, United States, 37660
Sponsors and Collaborators
Cordis Corporation
Investigators
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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
Publications of Results:
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Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00403078    
Other Study ID Numbers: P06-3603
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020
Keywords provided by Cordis Corporation:
Carotid Artery Stenting (Endovascular)
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases