Menu
Recruiting NCT05911568

Treatment With Endovascular Intervention for STroke Patients With Existing Disability

— Observational Stroke Stroke, Acute Stroke, Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endovascular Stroke Treatment, Medical Management.
Who it may be relevant to
Registry conditions: Stroke, Stroke, Acute, Stroke, Ischemic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • modified Rankin Scale (mRS) [Time frame: 90 (±14) days after treatment initiation]
Secondary outcome measures (4)
  • Disability-weighted (or utility-weighted) mRS [Time frame: 90 (±14) days after treatment initiation]
  • Return to the pre-stroke mRS level [Time frame: 90 (±14) days after treatment initiation]
  • EQ-5D-5L [Time frame: 90 (±14) days after treatment initiation]
  • Academic Medical Center - Linear Disability Scale (ALDS) [Time frame: 90 (±14) days after treatment initiation]

Eligibility criteria

Inclusion criteria

  • Adult patients (≥18 years)
  • Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset
  • Presenting to study hospital within 24 hours of last known well time
  • Diagnosis of acute ischemic stroke
  • 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
  • Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4
  • Presenting NIH Stroke Scale score ≥6
  • Informed consent from patient if competent or from legally authorized representative

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 25 centers
  • HonorHealth — Phoenix
  • Kaiser Permanente Los Angeles Medical Center — Los Angeles
  • University of California at Los Angeles — Los Angeles
  • Standford — Palo Alto
  • University of Cincinnati San Diego — San Diego
  • Swedish Medical Center — Englewood
  • Hartford Health Hospital — Hartford
  • Yale University — New Haven
  • … and 17 more centers

Identifiers

NCT: NCT05911568 · 2023-0299

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗