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Endovascular Revascularization of Symptomatic Chronically Occluded Internal Carotid Artery

NCT03176420 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-30

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

angioplasty and stenting of occluded cervical ICA

The procedure is performed under monitored anesthetic care. We will perform a thorough and complete six-vessel diagnostic angiogram to completely characterize the occlusion and presence of collaterals. A distal protection device is used unless technically can't be delivered beyond the occlusion or when the occlusion extends beyond the petrous segment of the internal carotid artery. Balloon angioplasty is performed followed by deployment of covered stents to jail the clot/organized thrombus. The carotid reconstruction is performed from the distal to the proximal segment with coronary stents that are telescoped until normal flow is encounter. The Blood pressure is managed rigorously during and after the procedure to minimize the chances of reperfusion hemorrhage.

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-03-31
Completion
2023-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176420 on ClinicalTrials.gov