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

Carotid Artery Disease - CHOICE

Trial Sponsor
Abbott Vascular

Principal Investigator
Gregory J. Mishkel, MD

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

Purpose
The purpose 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.

Details
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.

Phase
Phase IV

Study Type
Interventional

Study Design
Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Study Arms
1

Expected Enrollment
5000

Study Start
October 2006

Expected Completion
December 2008

Primary Outcome Measures

Composite of death, stroke, and MI (DSMI) at 30 days.

Eligibility

Genders Eligible for Study
Both

Inclusion Criteria

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

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