CHOICE: Carotid Stenting For High Surgical-Risk Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00406055
First received: November 29, 2006
Last updated: July 24, 2013
Last verified: July 2013

November 29, 2006
July 24, 2013
October 2006
June 2012   (final data collection date for primary outcome measure)
Composite of death, stroke, and MI (DSMI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Composite of death, stroke, and MI (DSMI) at 30 days.
Complete list of historical versions of study NCT00406055 on ClinicalTrials.gov Archive Site
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CHOICE: Carotid Stenting For High Surgical-Risk Patients
Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence

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.

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients enrolled into this registry will be male and female patients derived from the general population who satisfy the inclusion and exclusion criteria.

Carotid Artery Disease
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.
1
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.
Intervention: Device: RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18855
June 2012
June 2012   (final data collection date for primary outcome measure)

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

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00406055
06-717
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Abbott Vascular
Abbott Vascular
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Study Chair: William Gray, M.D.
Abbott Vascular
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP