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

Completed

• Conditions: Carotid Artery Disease

• Registration Number: NCT00403078
• Lead Sponsor: Cordis Corporation

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

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Primary Completion: 2014-07
• Study Completion: 2014-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21008

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any death, stroke or any MI	up to 30-days post-procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

The Heart Center, PC; 🇺🇸 Kingsport, Tennessee, United States

Iowa Clinic, Heart & Vascular Care; 🇺🇸 West Des Moines, Iowa, United States

Harrisburg Hospital; 🇺🇸 Harrisburg, Pennsylvania, United States

Bryan LGH Heart Institute; 🇺🇸 Lincoln, Nebraska, United States

Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States