Carotid Artery Disease - SAPPHIRE

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Trial Sponsor
Cordis

Principal Investigator
Gregory Mishkel, MD

Trial Name
Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide).

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).

Details
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..

Phase
Phase IV

Study Type
Observational

Study Design
Prospective

Study Arms
1

Expected Enrollment
10000

Study Start
October 2006

Expected Completion
February 2010

Primary Outcome Measures

• The primary objective of this study is to assess 30-day outcomes of stenting
• any death, stroke and MI with distal protection in the treatment of obstructive carotid
• Artery disease in relation to 30-day outcomes in the SAPPHIRE and CASES trials

Eligibility

Ages Eligible for Study
18 years or older

Genders Eligible for Study
Both

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
• Inability or refusal to provide informed consent.

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