Trial record 1 of 1 for:
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00403078 |
Recruitment Status
: Unknown
Verified February 2014 by Cordis Corporation.
Recruitment status was: Recruiting
First Posted
: November 23, 2006
Last Update Posted
: February 10, 2014
|
Sponsor:
Cordis Corporation
Information provided by (Responsible Party):
Cordis Corporation
Tracking Information | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date | November 20, 2006 | ||||||||||||
First Posted Date | November 23, 2006 | ||||||||||||
Last Update Posted Date | February 10, 2014 | ||||||||||||
Study Start Date | October 2006 | ||||||||||||
Estimated Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures |
Any death, stroke or any MI [ Time Frame: up to 30-days post-procedure ] | ||||||||||||
Original Primary Outcome Measures | Not Provided | ||||||||||||
Change History | Complete list of historical versions of study NCT00403078 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures |
|
||||||||||||
Original Secondary Outcome Measures | Not Provided | ||||||||||||
Current Other Outcome Measures | Not Provided | ||||||||||||
Original Other Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title | 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) | ||||||||||||
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 Type | Observational | ||||||||||||
Study Design | Time Perspective: Prospective | ||||||||||||
Target Follow-Up Duration | Not Provided | ||||||||||||
Biospecimen | Not Provided | ||||||||||||
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. | ||||||||||||
Condition | Carotid Artery Disease | ||||||||||||
Intervention | Not Provided | ||||||||||||
Study Groups/Cohorts | Not Provided | ||||||||||||
Publications * | 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. | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||
Recruitment Information | |||||||||||||
Recruitment Status | Unknown status | ||||||||||||
Estimated Enrollment |
21000 | ||||||||||||
Original Enrollment |
10000 | ||||||||||||
Estimated Study Completion Date | November 2014 | ||||||||||||
Estimated Primary Completion Date | July 2014 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
Sex/Gender |
|
||||||||||||
Ages | 18 Years and older (Adult, Senior) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number | NCT00403078 | ||||||||||||
Other Study ID Numbers | P06-3603 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | Cordis Corporation | ||||||||||||
Study Sponsor | Cordis Corporation | ||||||||||||
Collaborators | Not Provided | ||||||||||||
Investigators |
|
||||||||||||
PRS Account | Cordis Corporation | ||||||||||||
Verification Date | February 2014 |