CHOICE: Carotid Stenting For High Surgical-Risk Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Composite of death, stroke, and MI (DSMI) [30 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient or patient's legally authorized representative provided informed consent.
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Patient is considered at high risk for carotid endarterectomy (CEA).
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Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abbott Vascular | Santa Clara | California | United States | 95054 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Chair: William Gray, M.D.,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 06-717