NCT00406055

CHOICE: Carotid Stenting For High Surgical-Risk Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18,855 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

Conditions

• Carotid Artery Disease

Interventions

Type	Name	Description
DEVICE	RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6	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.

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2006-12-04
• Last updated: 2013-07-26

Locations

1 site across 1 country: United States