Clinical Trial: CHOICE: Carotid Stenting For High Surgical-Risk Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence

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 Summary: The CHOICE study will provide a mechanism for collection of data from Abbott Vascular's 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.
Sponsor: Abbott Vascular

Current Primary Outcome: Composite of death, stroke, and MI (DSMI) [ Time Frame: 30 days ]

Original Primary Outcome: Composite of death, stroke, and MI (DSMI) at 30 days.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Abbott Vascular

Dates:
Date Received: November 29, 2006
Date Started: October 2006
Date Completion:
Last Updated: July 24, 2013
Last Verified: July 2013