NeuroCognition After Carotid Recanalization

• Status: Recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: David Hasan
• Treatments: Aspirin; Clopidogrel

Criteria

Inclusion Criteria:

• Age ≥ 21

• Complete occlusion of cervical ICA on imaging studies (MRA or CTA) and confirmed with DSA

• History of TIA or stroke

• increased MTT and/or TPP on CTP in the ipsilateral side of the occluded ICA specifically in the middle cerebral artery (MCA) territory when compared to the opposite unaffected hemisphere

• If this criteria is NOT present: subject may be eligible for non-randomized third arm

• All occlusion is due to atherosclerotic disease

• MoCA < 26

Exclusion Criteria:

• Non-atherosclerotic occlusive disease that may have caused the occlusion, including moyamoya, dissection, trauma or other causes

• Tandem occlusion

• No evidence of increased MTT and /or PTT on CT perfusion

• Severe co-morbid diseases: end-stage renal disease, renal insufficiency, liver cirrhosis, chronic obstructive pulmonary disease (COPD) requiring home oxygen, terminal illness such as cancer, Parkinson disease or other neurodegenerative diseases, severe cognitive heart failure, seizures, debilitating stroke, modified Rankin scale (mRS) ≥3.

• Short life expectancy due to cancer or other co-morbid diseases

• Class D on COICA classification