Clinical trial NCT00403078: SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
Official title: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Disease
Keywords: Carotid Artery Stenting (Endovascular)
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 21008
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will consist of high-surgical risk patients with atherosclerotic disease of the carotid artery(ies) from up to 350 clinical sites in the US and Canada.

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

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.

Primary outcomes:
measure: Any death, stroke or any MI
timeFrame: up to 30-days post-procedure
Secondary outcomes:
measure: 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
timeFrame: 30 days
measure: Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled
timeFrame: Every follow-up where a PRO instrument QoL was assessed
measure: Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment
timeFrame: 1 year
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services
state: Delaware
city: West Des Moines
country: United States
facility: Iowa Clinic, Heart & Vascular Care
state: Iowa
city: Lincoln
country: United States
facility: Bryan LGH Heart Institute
state: Nebraska
city: Harrisburg
country: United States
facility: Harrisburg Hospital
state: Pennsylvania
city: Kingsport
country: United States
facility: The Heart Center, PC
state: Tennessee
Study officials:
affiliation: Harrisburg Hospital, 2808 Old Post Rd., Harrisburg, PA 17110
name: Rajesh Dave, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bryan LGH Heart Institute, 1500 South 48th St, Suite 400, Lincoln, NE 68506
name: Robert Hibbard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iowa Clinic-Heart and Vascular Care, 5950 University Ave, West Des Moines, IA 50266
name: Douglas Massop, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Heart Center, PC, 2050 Meadowview Parkway, Kingsport, TN 37660
name: Christopher Metzger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 first 2,001 patients. Catheter Cardiovasc Interv. 2009 Feb 1;73(2):129-36. doi: 10.1002/ccd.21844.