NCT04219774CompletedPhase 2
NeuroCognition After Carotid Recanalization
Neurocognitive Impairment Assessment in Symptomatic Carotid Occlusion Recanalized Endovascularly
Source: ClinicalTrials.gov · Last updated 9 May 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 31 Dec 2019
- Start date
- 1 May 2020
- Primary completion date
- 14 Mar 2024
- Lead sponsor
- Duke University
- Diseases
- Stroke
- NCT number
- NCT04219774
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 25
- From 1 May 2020 to the primary completion date, 14 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject unwilling to randomized to surgical procedure
Other illness
- Non-atherosclerotic occlusive disease that may have caused the occlusion, including moyamoya, dissection, trauma or other causes
- 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
Other
- Tandem occlusion
- No evidence of penumbra on CT perfusion
- Class D on COICA classification
- Normal neuropsychological battery test results
- Pregnant or risk of becoming pregnant
Who the study is looking for
- 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)
Age in the registry: 21 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.