Endovascular Revascularization of Symptomatic Chronically Occluded Internal Carotid Artery

NCT03176420 | Withdrawn

• 1 other identifier: UIHC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Stroke; Occlusion Carotid

Outcome Measures

Primary Outcomes (1)

• Endovascular revascularization that improves cognitive outcome

  This is one outcome that reflects the overall cognition. The composite cognitive score at 12-month follow-up is assessed by a composite z score based on the average z score for the tests for each subject (sum of the z scores divided by the number of tests included) from a specifically designed battery of 14 cognitive tests. Scores from tests in the proposed neuropsychological battery will be converted to z-scores. This is the following battery: Montreal Cognitive Assessment (MoCA),Wide Range Achievement Test-5 (WRAT-5); Wechsler Adult Intelligence Scale - IV (WAIS-IV); WAIS-IV, Coding subtest; WAIS-IV, Matrix Reasoning subtest; Hopkins Verbal Learning Test ; Benton Visual Retention Test (BVRT) ; Controlled Oral Word Association (COWA) Test; Boston Naming Test;Boston Diagnostic Aphasia Examination, Complex Ideational Material subtest;Trail-Making Test, part A and part B; Beck Depression Inventory-Fast Screen (BDI-FS);Iowa Scales of Personality Change (ISPC).

  12-month

Secondary Outcomes (1)

• safety of the procedure

  12-month

Other Outcomes (3)

• biomarkers of cognition - Lactate : tertiary outcomes

  12-month

• biomarkers of cognition - size of amygdala and hippocampus : tertiary outcomes

  12-month

• biomarkers of cognition - MTT : tertiary outcomes

  12-month

Study Arms (2)

Interventional arm

EXPERIMENTAL

Endovascular treatment of occluded carotids

Procedure: angioplasty and stenting of occluded cervical ICA

medical arm

NO INTERVENTION

maximal medical therapy of occluded carotids

Interventions

angioplasty and stenting of occluded cervical ICA PROCEDURE

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.

Interventional arm

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

MeSH Terms

Conditions

Stroke

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 randomization to maximal medical therapy vs endovascular intervention

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 5, 2017
• Study Start: March 1, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share