SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

Cordis

Status: Completed

Conditions: Carotid Artery Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00403078

P06-3603

Details and patient eligibility

About

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).

Full description

Carotid Artery Stenting

Enrollment: 21,008 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Patients previously enrolled in the study
• Patients requiring stenting of in-stent restenosis after CAS
• Inability or refusal to provide informed consent.