Phase 2
N=31
NeuroCognition After Carotid Recanalization
Cognition Disorder · Stroke · Occlusion Carotid
Bottom Line
View on ClinicalTrials.gov: NCT04219774 ↗Enrolled (actual)
31
Serious AEs
48.4%
Results posted
May 2025
Primary outcome: Primary: Change in Montreal Cognitive Assessment (MoCA) Score — 0.56; 1.38; -0.75; 0.50 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Endovascular intervention (Procedure); Aspirin and Clopidogrel (maximal medical Therapy) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Montreal Cognitive Assessment (MoCA) Score |
0.56; 1.38; -0.75; 0.50; -0.80; -0.33 | — |
| PRIMARY Change in Composite Cognitive Score |
0.18; -0.005; 0.065; 0.36; 0.29; 0.26 | — |
| SECONDARY Number of Participants With Stroke Within 30 Days Post Procedure |
0; 1; 0 | — |
| SECONDARY Number of Participants With Intracranial Hemorrhage Within 72 Hours Post Procedure |
1; 0; 0 | — |
| SECONDARY Number of Participant Deaths |
1; 1; 0 | — |
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
Eligibility 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 time to peak (TTP) on CT perfusion as defined as T Max threshold of > 10cc > 4 seconds in the territory of the occluded carotid specifically in the MCA territory when compared to the opposite unaffected hemisphere (not required for observational cohort)
- All occlusion is due to atherosclerotic disease
- MoCA < 26 or abnormal result on another test in the battery (abnormal defined as 1.5 SD below age/ gender/ education matched norms).
- Baseline MoCA assessed by the neurosurgery team or neuropsychology team
- Failed best medical treatment (defined below)
- Class A and B on COICA Classification
- Study team able to gain consent from subject or legal adult representative (LAR)
Exclusion Criteria
- Non-atherosclerotic occlusive disease that may have caused the occlusion, including moyamoya, dissection, trauma or other causes
- Tandem occlusion
- No evidence of penumbra on CT perfusion
- Severe co-morbid diseases: Chronic Kidney Disease (CKD) stages 4 or 5, end-stage renal disease, liver cirrhosis; Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen; terminal illness such as cancer; Parkinson disease or other neurodegenerative diseases; severe congestive heart failure; seizures; debilitating stroke, Modified Rankin Score (mRS) ≥ 3
- Short life expectancy due to cancer or other co-morbid diseases
- Class D on COICA classification
- Normal neuropsychological battery test results
- Subject unwilling to randomized to surgical procedure
- Pregnant or risk of becoming pregnant
Data sourced from ClinicalTrials.gov (NCT04219774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.