Abbot RX Acculink with RX Accunet OR Xact stent with Emboshield (CHOICE)
- Type of Study
- Heart & Vascular - Peripheral Trials
- Cherry Hill Campus
- Short Description
The purpose of this study is to collect data about patients' medical experiences and conditions following treatment of carotid stenosis using one of Abbott Vascular's carotid stent systems and embolic protection systems. The names of the two stents are the RX Acculink® Carotid Stent System (the "RX Acculink" device or system) and the Xact® Rapid Exchange Carotid Stent System (the "Xact stent" device or system). The names of the embolic protection systems are the RX Accunet™ Embolic Protection System (the "RX Accunet" device or system) and Emboshield® BareWire™ Rapid Exchange Embolic Protection System (the "Emboshield filter" device or system). All of these devices have been approved/cleared by the U.S. Food and Drug Administration ("FDA").
- Principal Investigator
- Robert Bersin, MD
- Eligibility Notes
- Patient or patient's legally authorized representative provided consent.
- Patient is considered at high risk for carotid endarterectomy (CEA).
- Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
- Patient's physician intends to use an RX Acculink with the RX Accunet or an Xact with the Emboshield in the carotid artery as per the FDA-approved indication for use outlined below:
- Patients with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram,
- Patients without neurological symptoms and >= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram.
There are no exclusion criteria for this study.
- Start Date
- Contact Name
- Kathleen Butler