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

Cordis Corporation5 sites in 1 country21,008 target enrollmentOctober 2006

ConditionsCarotid Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Carotid Artery Disease
Sponsor: Cordis Corporation
Enrollment: 21008
Locations: 5
Primary Endpoint: Any death, stroke or any MI
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 PRECISE® Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).

Detailed Description

Carotid Artery Stenting

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

November 2014

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cordis Corporation

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Any death, stroke or any MI

Time Frame: up to 30-days post-procedure

Secondary Outcomes

Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled(Every follow-up where a PRO instrument QoL was assessed)
Assess the consistency of MAE rates of stenting with distal protection in the treatment of obstructive carotid artery disease among high, medium and low volume centers with physicians who have validated CASES training levels of 1, 2, 2P or 3(30 days)
Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment(1 year)