RECRUITING

Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

TESTED will compare the risks and benefits of endovascular thrombectomy (EVT) to medical management (no EVT) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.

Official Title

Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Quick Facts

Study Start:2023-11-16

Study Completion:2028-04-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05911568

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Adult patients (≥18 years) 2. Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset 3. Presenting to study hospital within 24 hours of last known well time 4. Diagnosis of acute ischemic stroke 5. Intracranial causative occlusion of the internal carotid artery or the M1 or dominant M2 segments of the middle cerebral artery visualized on the baseline CT(or MR) angiogram 6. Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4 7. Presenting NIH Stroke Scale score ≥6 8. Informed consent from patient if competent or from legally authorized representative	1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke 2. Assessment of pre-stroke functional status cannot be performed during the hospital stay 3. Pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)

Inclusion Criteria

Exclusion Criteria

1. Adult patients (≥18 years)
2. Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset
3. Presenting to study hospital within 24 hours of last known well time
4. Diagnosis of acute ischemic stroke
5. Intracranial causative occlusion of the internal carotid artery or the M1 or dominant M2 segments of the middle cerebral artery visualized on the baseline CT(or MR) angiogram
6. Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4
7. Presenting NIH Stroke Scale score ≥6
8. Informed consent from patient if competent or from legally authorized representative

1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke
2. Assessment of pre-stroke functional status cannot be performed during the hospital stay
3. Pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)

Contacts and Locations

Study Contact

Eva Mistry, MD

CONTACT

513-558-1291

mistryea@ucmail.uc.edu

Naima Griffin

CONTACT

513-558-0125

griffna@ucmail.uc.edu

Principal Investigator

Eva Mistry, MD

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Jeffrey Saver, MD

PRINCIPAL_INVESTIGATOR

Ronald Reagan UCLA Medical Center

J Mocco, MD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Heidi Sucharew, PhD

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Study Locations (Sites)

HonorHealth

Phoenix, Arizona, 85013

United States

University of California at Los Angeles

Los Angeles, California, 90095

United States

Hartford Health Hospital

Hartford, Connecticut, 06106

United States

Yale University

New Haven, Connecticut, 06510

United States

University of Miami

Miami, Florida, 33125

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Columbia University

New York, New York, 10032

United States

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

University of Washington

Seattle, Washington, 98104

United States

West Virginia University

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: University of Cincinnati

Eva Mistry, MD, PRINCIPAL_INVESTIGATOR, University of Cincinnati
Jeffrey Saver, MD, PRINCIPAL_INVESTIGATOR, Ronald Reagan UCLA Medical Center
J Mocco, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
Heidi Sucharew, PhD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-16

Study Completion Date2028-04-15

Study Record Updates

Study Start Date2023-11-16

Study Completion Date2028-04-15

Terms related to this study

Additional Relevant MeSH Terms

Stroke
Stroke, Acute
Stroke, Ischemic