Trial Information

Summary: Sapphire WW - Stenting and Angioplasty with protection in patients at high-risk for endarterectomy protocol synopsis (AMENDMENT 1)

OBJECTIVE:
The primary objective of this study is to estimate 30-day MAE rate of stenting (any death, stroke or any MI) with distal protection in the treatment of obstructive carotid artery disease in high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). 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).

OVERVIEW OF STUDY DESIGN:
This is a multi-center, prospective, observational study.

STUDY POPULATION:
The study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies). There will be approximately 275 clinical sites from the US, Canada, Latin America, Europe and Asia Pacific participating in this study, enrolling up to 10,000 patients. There will be centers included that perform low, medium and high annual carotid stent implant volumes, from both academic and private hospitals, and across geographic locations. Consented high-surgical risk patients, treated as per the IFU labeling, will be enrolled.

Inclusion Criteria:
Please refer to the Instructions For Use (IFU) in order to determine eligibility for the registry.

Candidates for this study must meet the following 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 3. Inability or refusal to provide informed consent.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.