CHOICE: Carotid Stenting For High Surgical-Risk Patients
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence
Eligibility 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.
- There are no exclusion criteria for this study
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Ronald Dalman
6507255227
View on ClinicalTrials.gov
