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Occlusion Carotid clinical trials

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NCT ID: NCT03176420 Withdrawn - Stroke Clinical Trials

Endovascular Revascularization of Symptomatic Chronically Occluded Internal Carotid Artery

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

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.