IRB Study Number 21-849
Status Recruiting
Phase Phase 2
Institute Heart and Vascular Institute
Description
The purpose of this study is to see whether the CGuard stent is safe for patients and to make sure it is effective in opening the narrowing in the carotid artery to improve blood flow to the brain.
You are eligible for this study if your doctor plans to perform carotid artery stenting to treat the narrowing in your carotid arteries. In the stenting procedure, a small tube made of wire mesh, which is called a stent, is placed inside the narrowed artery in the neck. The stent is placed into the artery through a small plastic tube (“catheter”) inserted through a small skin puncture under local anesthesia. Injections of x‐ray dye are made through the catheter to take x‐ray pictures of the narrowing. This is called angiography. Once your doctor determines that the narrowing meets requirements, the stent is placed across the narrowing, then the stent is opened out where it is designed to act like a spring to keep the artery open.
Inclusion Criteria
Subject is diagnosed with carotid artery disease treatable with carotid artery stenting and is considered high risk for carotidendarterectomy (CEA).
Subject is willing and able to take dual antiplatelet therapy for a minimum of 30 days.
Exclusion Criteria
Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index carotid procedure.
History of bleeding or clotting issues. Vascular anatomy that is not compatible with the sizing of the device. (To be determined by your physician)
