Carotid Stenting for High Surgical-Risk Patients; Evaluating Outcomes Through the Collection of Clinical Evidence
To collect data about patients' medical experiences and conditions after treatment of carotid stenosis using one of Abbott Vascular’s carotid stent and embolic protection systems
James Williams, MD, FACS, FCCP, FACC
Cardiac, Thoracic and Endovascular Therapies
Marco Barzallo, MD
Syed Hussain, MD
Subhash J. Patel, MD, FACC, FACP
Albina Underwood, RN (309) 672-4767
Patients with carotid artery disease often have a significant narrowing that can cause a stroke or short-lived blindness. It has been shown that widening the narrowed portion of the artery will reduce the risk of a stroke in the future. One treatment for carotid artery disease involves placing a stent in the narrowed artery to open it and increase blood flow to the brain. Two devices will be used in this study for carotid artery stenting:
Emboshield BareWire Rapid Exchange Embolic Protection System (the Emboshield filter) or Emboshield® Nav6 Embolic Protection System (the Nav6 filter device or system) and Xact Rapid Exchange Carotid Stent System (the Xact stent)
RX Accunet Embolic Protection System (RX Accunet) and RX Acculink Carotid Stent System (RX Acculink)
The Emboshield filter, Nav6 filter and the RX Accunet are used to catch particles that may break off from the narrowed area of the artery. This material could block blood flow to the arteries beyond the narrowed area of the artery and be harmful to the brain. The Xact stent and the RX Acculink are an elastic-like metal tube that is used to hold open a narrow part of a blood vessel. This stent will be permanently implanted. Once the stent is implanted, the embolic protection system will be removed. The study doctor will choose which system to use before the procedure. Patients who receive the stent will be seen by their doctor 30 days after the procedure for a check-up to see that the stent is working well and to see if they have had complications from the procedure. The neurologist or the study nurse will perform a neurological exam before the procedure, within 24 hours after the procedure and at the 30 day follow up visit. The study will collect information about any side effects that the patient has had after treatment with the stent.
The FDA-approved Xact and Acculink Carotid Stent Systems are being used for this study under the indications for use of the device. Additionally, the Emboshield and Accunet Embolic protection Systems are being used for this study under the cleared indications for use.
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