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

Carotid Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403078
• Other study ID #: P06-3603
• Status: Completed
• Start date: October 2006
• Est. completion date: November 2014

Study information

• Verified date: August 2020
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Carotid Artery Stenting

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21008
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carotid Artery Disease
• Carotid Artery Diseases

Locations

Country	Name	City	State
United States	Harrisburg Hospital	Harrisburg	Pennsylvania
United States	The Heart Center, PC	Kingsport	Tennessee
United States	Bryan LGH Heart Institute	Lincoln	Nebraska
United States	Christiana Care Health Services	Newark	Delaware
United States	Iowa Clinic, Heart & Vascular Care	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Massop D, Dave R, Metzger C, Bachinsky W, Solis M, Shah R, Schultz G, Schreiber T, Ashchi M, Hibbard R; SAPPHIRE Worldwide Investigators. Stenting and angioplasty with protection in patients at high-risk for endarterectomy: SAPPHIRE Worldwide Registry fir — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any death, stroke or any MI		up to 30-days post-procedure
Secondary	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
Secondary	Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled		Every follow-up where a PRO instrument QoL was assessed
Secondary	Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment		1 year