CHOICE: Carotid Stenting For High Surgical-Risk Patients

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00406055
Study type	Observational
Source	Abbott Vascular
Contact
Status	Completed
Phase	Phase 4
Start date	October 2006
Completion date	June 2012

View Details

See also
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