Transcarotid Artery Revascularization With Flow Reversal

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Neurointerventional Radiology

Background:

• Carotid artery stenosis poses a significant risk of stroke.
• Traditional carotid endarterectomy and transfemoral stenting have established roles.
• Direct carotid access offers an alternative approach for carotid revascularization.

Purpose of the Study:

• To evaluate the safety and efficacy of carotid artery stenting using direct carotid access.
• To assess the performance of the ENROUTE Transcarotid Neuroprotection System during the procedure.
• To determine the rate of stroke, myocardial infarction, and death within 30 days post-procedure.

Main Methods:

• Prospective study of 75 patients undergoing carotid artery stenting with the ENROUTE System.
• Primary endpoint: composite of major stroke, myocardial infarction, or death at 30 days.
• Diffusion-weighted MRI (DW-MRI) used to assess new ischemic brain lesions in 56 patients.

Main Results:

• High rates of acute device (90.6%) and procedure (90.6%) success.
• Successful flow reversal established in 94.6% of patients.
• No major stroke, myocardial infarction, or death occurred at 30 days; 1 minor stroke unrelated to the procedure.

Conclusions:

• Transcarotid revascularization with the ENROUTE Transcarotid Neuroprotection System is safe and effective.
• The procedure demonstrates favorable short-term safety and efficacy outcomes.
• Direct carotid access with flow reversal is a viable option for carotid artery stenting.