WithdrawnNot Applicable

Endovascular Revascularization of Symptomatic Chronically Occluded Internal Carotid Artery

Stopped: Study is not funded, PI has left the institution

0Started 2020-03-01

Plain-language summary

This is a phase 2 randomized single-center open label clinical trial with randomization of 1:1 to either best medical management vs. best medical management and endovascular revascularization of chronically occluded ICA (COICA). The study will utilize best medical management and will randomize patients to endovascular balloon angioplasty and stenting. Primary Objective: To test the hypothesis that endovascular revascularization of COICA improves significantly cognitive function assessed by a specifically designed battery of 14 cognitive tests including the Montreal Cognitive Assessment (MoCA). Secondary Objective: To test the safety of endovascular revascularization of chronically occluded ICA. Tertiary/exploratory Objectives: To test the hypothesis that subjects with symptomatic COICAs and mild/moderate cognitive dysfunction have the following biomarkers: A) Presence of lactate and decreased Naa/Cr in the watershed area (specifically centrum semiovale) on 1H-MRI-spectroscopy, and B) Decreased size of the hippocampus and amygdala on MRI. C) increased MTT on CTP in the ipsilateral side of the occluded ICA specifically in the MCA territory when compared to the opposite unaffected hemisphere.

Who can participate

Age range21 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 21 * Complete occlusion of cervical ICA on imaging studies (MRA or CTA) and confirmed with DSA * History of TIA or stroke within 120 days of enrollment * increased MTT on CTP in the ipsilateral side of the occluded ICA specifically in the MCA territory when compared to the opposite unaffected hemisphere * All occlusion is due to atherosclerotic disease * MoCA \< 26 but ≥23 Exclusion Criteria: * History of Moyamoya or Moyamoya like disease * Tandem occlusion * No evidence of increased MTT on CT perfusion * Severe co-morbid diseases: end-stage renal disease, liver cirrhosis, COPD requiring home oxygen, terminal illness such as cancer, Parkinson disease or other neurodegenerative diseases, severe cognitive heart failure, seizures, debilitating stroke, mRS ≥3. * Short life expectancy due to cancer or other co-morbid diseases * Class D on COICA classification

What they're measuring

Endovascular revascularization that improves cognitive outcome

Timeframe: 12-month

Trial details

NCT IDNCT03176420

SponsorUniversity of Iowa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31