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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Cordis Corporation
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00403078
First received: November 20, 2006
Last updated: February 7, 2014
Last verified: February 2014

November 20, 2006
February 7, 2014
October 2006
July 2014   (final data collection date for primary outcome measure)
Any death, stroke or any MI [ Time Frame: up to 30-days post-procedure ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00403078 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Assess the real-world cost-effectiveness of carotid artery stenting in subjects enrolled [ Time Frame: Every follow-up where a PRO instrument QoL was assessed ] [ Designated as safety issue: No ]
  • Estimate MAE (death and ipsilateral stroke) rate in a subset of the planned total enrollment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy (SAPPHIRE Worldwide)

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).

Carotid Artery Stenting

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Carotid Artery Disease
Not Provided
Not Provided
Massop D, Dave R, Metzger C, Bachinsky W, Solis M, Shah R, Schultz G, Schreiber T, Ashchi M, Hibbard R; on behalf of the 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. 2008 Oct 15; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
21000
November 2014
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Clinical Trial Triage 877-820-TRIAL
Contact: Amy Orlick 908-541-4347 aorlick@its.jnj.com
United States
 
NCT00403078
P06-3603
Yes
Cordis Corporation
Cordis Corporation
Not Provided
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
Cordis Corporation
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP