Clinical trial NCT05911568: Treatment With Endovascular Intervention for STroke Patients With Existing Disability
Official title: Treatment With Endovascular Intervention for STroke Patients With Existing Disability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Stroke, Acute
Stroke, Ischemic
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of California, Los Angeles
name: Icahn School of Medicine at Mount Sinai
First posted: 2023-06-22
Enrollment: 1060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. They will be consented up to 72 hours after stroke onset in the acute hospitalization setting.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: modified Rankin Scale (mRS)
timeFrame: 90 (±14) days after treatment initiation
Secondary outcomes:
measure: Disability-weighted (or utility-weighted) mRS
timeFrame: 90 (±14) days after treatment initiation
measure: Return to the pre-stroke mRS level
timeFrame: 90 (±14) days after treatment initiation
measure: EQ-5D-5L
timeFrame: 90 (±14) days after treatment initiation
measure: Academic Medical Center - Linear Disability Scale (ALDS)
timeFrame: 90 (±14) days after treatment initiation
Other outcomes:
measure: modified Rankin Scale (mRS)
timeFrame: At hospital discharge
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 90 (±14) days after treatment initiation
measure: Barthel Index Scale
timeFrame: 90 (±14) days after treatment initiation
measure: Initial residence level or better time during first 90 days post-stroke
timeFrame: 90 days after treatment initiation
measure: Zarit's Burden Interview (ZBI)
timeFrame: 90 (±14) days after treatment initiation
measure: Extended Thrombolysis in Cerebral Ischemia scale
timeFrame: At the end of EVT procedure
measure: Death
timeFrame: 90 (±14) after treatment initiation
measure: Symptomatic intracranial hemorrhage
timeFrame: 24 (±6) hours
Locations:
city: Phoenix
country: United States
facility: HonorHealth
state: Arizona
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Hartford
country: United States
facility: Hartford Health Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: University of Miami
state: Florida
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Cincinnati
name: Eva Mistry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ronald Reagan UCLA Medical Center
name: Jeffrey Saver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: J Mocco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Heidi Sucharew, PhD
role: PRINCIPAL_INVESTIGATOR
References: