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

Sponsor

Cordis Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00403078

Collaborator

(none)

21,008

Enrollment

Locations

Duration (Months)

4201.6

Patients Per Site

43.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease

Detailed Description

Carotid Artery Stenting

Study Design

Study Type:

Observational

Actual Enrollment :

21008 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Outcome Measures

Primary Outcome Measures

Any death, stroke or any MI [up to 30-days post-procedure]

Secondary Outcome Measures

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]
Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled [Every follow-up where a PRO instrument QoL was assessed]
Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christiana Care Health Services	Newark	Delaware	United States	19713
2	Iowa Clinic, Heart & Vascular Care	West Des Moines	Iowa	United States	50266
3	Bryan LGH Heart Institute	Lincoln	Nebraska	United States	68506
4	Harrisburg Hospital	Harrisburg	Pennsylvania	United States	17110
5	The Heart Center, PC	Kingsport	Tennessee	United States	37660

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator: Rajesh Dave, MD, Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110
Principal Investigator: Robert Hibbard, MD, Bryan LGH Heart Institute, 1500 South 48th St, Suite 400, Lincoln, NE 68506
Principal Investigator: Douglas Massop, MD, Iowa Clinic-Heart and Vascular Care, 5950 University Ave, West Des Moines, IA 50266
Principal Investigator: Christopher Metzger, MD, The Heart Center, PC, 2050 Meadowview Parkway, Kingsport, TN 37660

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cordis Corporation

ClinicalTrials.gov Identifier:

NCT00403078

Other Study ID Numbers:

P06-3603

First Posted:

Nov 23, 2006

Last Update Posted:

Aug 10, 2020

Last Verified:

Aug 1, 2020

Keywords provided by Cordis Corporation

Carotid Artery Stenting (Endovascular)

Additional relevant MeSH terms:

Carotid Artery Diseases

Study Results

No Results Posted as of Aug 10, 2020