Complete occlusion of the Internal carotid artery (ICA) by atherosclerotic disease (COICA)
causes approximately 15%-25% of ischemic strokes in the carotid artery distribution. Patients
treated with medical therapy have a 7%-10% risk of recurrent stroke per year for any stroke
and a 5%-8% risk per year for ipsilateral ischemic stroke during the first 2 years after ICA
occlusion. Internal carotid artery occlusion causes an estimated 61,000 first-ever strokes
per year in the US an incidence more than twice the annual occurrence of ruptured
intracranial aneurysms Additionally, 40% of subjects with COICA who present with transient
ischemic attack (TIA) and 70% of COICA who present with stroke have cognitive decline with
increased risk of vascular dementia and Alzheimer's' disease (AD) with time (2,3).
Symptomatic COICA subjects are at increased risk of developing cognitive impairment and
progressive development of vascular dementia and AD with time. Our proposal leverages several
compelling retrospective and prospective preliminary data from human to perform this
exploratory trial with go/no-go criteria to proceed to a phase 3 based on the data generated