Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Jeffrey Saver, MD

Description

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.

Details

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.

Keywords

Stroke, Stroke, Acute, Stroke, Ischemic, Ischemic Stroke, Endovascular Stroke Treatment, Medical Management

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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)

Locations

  • University of California at Los Angeles not yet accepting patients
    Los Angeles California 90095 United States
  • HonorHealth not yet accepting patients
    Phoenix Arizona 85013 United States
  • University of Cincinnati Medical Center accepting new patients
    Cincinnati Ohio 45219 United States

Lead Scientist at UCLA

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
University of Cincinnati
Links
Sign up for this study
ID
NCT05911568
Study Type
Observational
Participants
Expecting 1060 study participants
Last Updated