Status:
COMPLETED
CHOICE: Carotid Stenting For High Surgical-Risk Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Carotid Artery Disease
Eligibility:
All Genders
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 wi...
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 u...
Eligibility Criteria
Inclusion
- 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 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
- There are no exclusion criteria for this study
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
18855 Patients enrolled
Trial Details
Trial ID
NCT00406055
Start Date
October 1 2006
End Date
June 1 2012
Last Update
July 26 2013
Active Locations (1)
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1
Abbott Vascular
Santa Clara, California, United States, 95054