Treatment With Endovascular Intervention for STroke Patients With Existing Disability
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endovascular Stroke Treatment
Procedure/SurgeryPatients 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
Medical Management
Other interventionPatients 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.
Treatment groups
1,060 Participants
are divided into 1 treatment groupGroup A: Stroke patients with moderate-to-severe pre-stroke disability2 interventions
Trial outcomes
Primary outcomes
1
modified Rankin Scale (mRS)
Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)
Time frame
90 (±14) days after treatment initiationSecondary outcomes
1
Disability-weighted (or utility-weighted) mRS
Standard utility weights applied to the mRS categories as follows: 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6
Time frame
90 (±14) days after treatment initiation2
Return to the pre-stroke mRS level
Returning to the pre-stroke mRS level post stroke
Time frame
90 (±14) days after treatment initiation3
EQ-5D-5L
Quality of life assessment scale with range: 0 (worst health) to 100 (best health)
Time frame
90 (±14) days after treatment initiation4
Academic Medical Center - Linear Disability Scale (ALDS)
Generic item bank that measures the disability status of patients with a broad range of diseases, as expressed by the ability to perform activities in daily living.
Time frame
90 (±14) days after treatment initiationOther outcomes
1
modified Rankin Scale (mRS)
Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)
Time frame
At hospital discharge2
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) (Note: MoCA range: 0-30, higher scores mean better outcome)
Time frame
90 (±14) days after treatment initiation3
Barthel Index Scale
Barthel Index range: 0-100, higher scores mean participant is independent
Time frame
90 (±14) days after treatment initiation4
Initial residence level or better time during first 90 days post-stroke
Number of days spend at the initial residence level or better during the first 90 days post-stroke
Time frame
90 days after treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cincinnati
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of California, Los Angeles
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Source ClinicalTrials.gov