Status:
COMPLETED
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
Lead Sponsor:
Cordis US Corp.
Conditions:
Carotid Artery Disease
Eligibility:
All Genders
18+ years
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 PRECI...
Detailed Description
Carotid Artery Stenting
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
21008 Patients enrolled
Trial Details
Trial ID
NCT00403078
Start Date
October 1 2006
End Date
November 1 2014
Last Update
August 10 2020
Active Locations (5)
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1
Christiana Care Health Services
Newark, Delaware, United States, 19713
2
Iowa Clinic, Heart & Vascular Care
West Des Moines, Iowa, United States, 50266
3
Bryan LGH Heart Institute
Lincoln, Nebraska, United States, 68506
4
Harrisburg Hospital
Harrisburg, Pennsylvania, United States, 17110