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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death, stroke, and MI (DSMI) | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
There are no exclusion criteria for this study
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Patients enrolled into this registry will be male and female patients derived from the general population who satisfy the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| William Gray, M.D. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Vascular | Santa Clara | California | 95054 | United States |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |