SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
NCT ID: NCT00403078
Last Updated: 2020-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
21008 participants
OBSERVATIONAL
2006-10-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Cordis Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Rajesh Dave, MD
Role: PRINCIPAL_INVESTIGATOR
Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110
Robert Hibbard, MD
Role: PRINCIPAL_INVESTIGATOR
Bryan LGH Heart Institute, 1500 South 48th St, Suite 400, Lincoln, NE 68506
Douglas Massop, MD
Role: PRINCIPAL_INVESTIGATOR
Iowa Clinic-Heart and Vascular Care, 5950 University Ave, West Des Moines, IA 50266
Christopher Metzger, MD
Role: PRINCIPAL_INVESTIGATOR
The Heart Center, PC, 2050 Meadowview Parkway, Kingsport, TN 37660
Locations
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Christiana Care Health Services
Newark, Delaware, United States
Iowa Clinic, Heart & Vascular Care
West Des Moines, Iowa, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, United States
Harrisburg Hospital
Harrisburg, Pennsylvania, United States
The Heart Center, PC
Kingsport, Tennessee, United States
Countries
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References
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Massop D, Dave R, Metzger C, Bachinsky W, Solis M, Shah R, Schultz G, Schreiber T, Ashchi M, Hibbard R; 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. 2009 Feb 1;73(2):129-36. doi: 10.1002/ccd.21844.
Other Identifiers
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P06-3603
Identifier Type: -
Identifier Source: org_study_id
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