CHOICE: Carotid Stenting For High Surgical-Risk Patients

Completed

• Conditions: Carotid Artery Disease
• Interventions: Device: RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6

• Registration Number: NCT00406055
• Lead Sponsor: Abbott Medical Devices

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 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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-30
• Study First Posted: 2006-12-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-24
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18855

Inclusion Criteria

1. Patient or patient's legally authorized representative provided informed consent.
2. Patient is considered at high risk for carotid endarterectomy (CEA).
3. Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
4. Patients physician intends to use an RX Acculink with either the RX Accunet or Emboshield Nav 6 in the carotid artery OR the patients physician intends to use an Xact with the Emboshield or Emboshield Nav6 in the carotid artery as per the FDA approved Indications for Use as outlined.

Exclusion Criteria

There are no exclusion criteria for this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	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.

Primary Outcome Measures

Name	Time	Method
Composite of death, stroke, and MI (DSMI)	30 days

Trial Locations

Locations (1)

Abbott Vascular; 🇺🇸 Santa Clara, California, United States