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 (blockages in carotid arteries). The devices to be utilized are the Cordis PRECISE® Nitinol Stent Systems 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).

Ages Eligible for Study
18 years or older

Genders Eligible for Study
Both

Inclusion Criteria

• High-surgical risk patients
• The patient or legally authorized representative has signed a written informed consent and HIPAA authorization prior to the procedure

Exclusion Criteria

• Patients that cannot be treated as outlined in the device manufactures instructions
• Inability or refusal to provide informed consent.

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