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CHOICE: Carotid Stenting For High Surgical-Risk Patients
Trial ID: NCT00406055
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.
Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence
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
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.
There are no exclusion criteria for this study
device: RX ACCULINK , RX ACCUNET , XACT , EMBOSHIELD and EMBOSHIELD Nav6
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