CHOICE: Carotid Stenting For High Surgical-Risk Patients - Full Text View

Sponsored by:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00406055

Purpose

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.

Condition	Intervention	Phase
Carotid Artery Disease	Device: RX ACCULINK , RX ACCUNET , XACT , and EMBOSHIELD	Phase IV

MedlinePlus related topics: Carotid Artery Disease Medicare

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

Composite of death, stroke, and MI (DSMI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	5000
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention 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.	Device: RX ACCULINK , RX ACCUNET , XACT , and EMBOSHIELD 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.
Patients 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.

Exclusion Criteria:

There are no exclusion criteria for this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406055

Contacts

Contact: Sharon Gordon

408.845.0699

Locations

United States, California
Abbott Vascular	Recruiting
Santa Clara, California, United States, 95054
Contact: Sharon Gordon 408-845-0699 sharon.gordon@av.abbott.com
Contact 800-633-3375

Sponsors and Collaborators

Abbott Vascular

Investigators

Study Chair:

William Gray, M.D.

Unaffiliated

More Information

Responsible Party:	Abbott Vascular ( Sharon Gordon )
Study ID Numbers:	06-717
Study First Received:	November 29, 2006
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00406055
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Vascular Diseases
Central Nervous System Diseases
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009