Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00406055
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2006-11-29
Brief Title:
CHOICE Carotid Stenting For High Surgical-Risk Patients
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Carotid Stenting For High Surgical-Risk Patients Evaluating Outcomes Through The Collection Of Clinical Evidence
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study is to 1 Provide additional information that the commercially available Abbott Vascular Carotid Stent Systems and Embolic Protection Systems can be used successfully by a wide range of physicians under commercial use conditions 2 Provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services CMS coverage to a broader group of patients
Detailed Description:
The CHOICE study will provide a mechanism for collection of data from Abbott Vasculars Carotid Stent Systems and Embolic Protection Systems when used by a broad group of physicians under commercial use conditions The original CAPTURE and EXACT studies had built-in features that limited the ability to collect on-going real world data because they restricted the number of sites that could participate up to 150 sites and limited enrollment at each site up to 50 patients per site This study will not have these restrictions The CHOICE study will also provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services CMS coverage to a broader group of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None