Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Purpose

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.

Conditions

  • Stroke
  • Stroke, Acute
  • Stroke, Ischemic

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  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)

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Stroke patients with moderate-to-severe pre-stroke disability Patients with pre-stroke modified Rankin scale score 3 or 4, presenting with a anterior circulation large vessel occlusion stroke within 24 hours of last known well
  • Procedure: Endovascular Stroke Treatment
    Patients who receive endovascular stroke treatment when they are admitted into the hospital, as determined by their clinical care team. Endovascular stroke treatment consist of catheter-based treatment for the blood clot causing the acute ischemic stroke
  • Other: Medical Management
    Patients who receive MMM when they are admitted into the hospital, as determined by their clinical care team. MMM may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care. Specifically, this treatment does not involve endovascular stroke treatment.

Recruiting Locations

HonorHealth
Phoenix, Arizona 85013
Contact:
Ashu Jadhav, MD

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Shayandokht Taleb, MD

University of California at Los Angeles
Los Angeles, California 90095
Contact:
Jeffrey Saver, MD

Standford
Palo Alto, California 94305
Contact:
Maarten Lansberg, MD

University of Cincinnati San Diego
San Diego, California 92121
Contact:
Brett Meyer, MD

Swedish Medical Center
Englewood, Colorado 80113
Contact:
Donald Frei, MD

Hartford Health Hospital
Hartford, Connecticut 06106
Contact:
Tapan Mehta, MD

Yale University
New Haven, Connecticut 06510
Contact:
Adam DeHavenon, MD

University of Miami
Miami, Florida 33125
Contact:
Robert Starke, MD

Emory University
Atlanta, Georgia 30322
Contact:
Brian Howard, MD

University of Chicago
Chicago, Illinois 60637
Contact:
James Siegler, MD

University of Louisville
Louisville, Kentucky 40202
Contact:
Isaac Josh Abecassis

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Mohamad AbdalKader, MD

Barnes Jewish Hospital
St Louis, Missouri 63110
Contact:
Charles Kircher, MD

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Shahram Majidi, MD

Columbia University
New York, New York 10032
Contact:
Joshua Wiley, MD

University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Contact:
Stacie Demel, DO, PhD

Providence St. Vincent Medical Center
Portland, Oregon 97225
Contact:
Amit Kansara, MD

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
Raul Nogueira, MD

Baptist Memorial Hospital
Memphis, Tennessee 38120
Contact:
Violiza Inoa, MD

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Michael Froehler, MD

University of Texas at Austin
Austin, Texas 78712
Contact:
Hamidreza Saber, MD

University of Washington
Seattle, Washington 98104
Contact:
David Tirschwell, MD

West Virginia University
Morgantown, West Virginia 26506
Contact:
Ansaar Rai, MD

More Details

Status
Recruiting
Sponsor
University of Cincinnati

Study Contact

Eva Mistry, MD
513-558-1291
mistryea@ucmail.uc.edu

Detailed Description

People with disabilities can suffer acute ischemic stroke (AIS). Endovascular clot removal is a breakthrough therapy for large vessel occlusion (LVO) AIS. Pre-stroke disabled patients were excluded from pivotal EVT stroke trials, so whether EVT is effective for those with pre-stroke disability is not known. As a result, two competing, widely-practiced, treatment paradigms have emerged based on individual practitioners' extrapolation of EVT benefits and safety from patients without a pre-stroke disability to those with disability: 1) Multimodal Medical Management (MMM; using intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol lowering medications, and other rehabilitative measures, as indicated) without EVT, and 2) EVT with the background of MMM. TESTED will enroll patients with LVO-AIS who have a pre-existing disability, defined as pre-stroke modified Rankin score (mRS) 3 and 4, at 12 geographically distinct comprehensive stroke centers serving diverse race-ethnic and socioeconomic populations. The central objective of TESTED is to determine the comparative effectiveness and safety of these two different practice paradigms.