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 range

21 Years – 90 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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