Treatment With Endovascular Intervention for STroke Patients With Existing Disability
Overview
- Phase
- Not Applicable
- Intervention
- Endovascular Stroke Treatment
- Conditions
- Stroke
- Sponsor
- University of Cincinnati
- Enrollment
- 1060
- Locations
- 36
- Primary Endpoint
- modified Rankin Scale (mRS)
- Status
- Recruiting
- Last Updated
- 17 days ago
Overview
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.
Investigators
Eva A. Mistry
Assistant Professor
University of Cincinnati
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)
Arms & Interventions
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
Intervention: Endovascular Stroke Treatment
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
Intervention: Medical Management
Outcomes
Primary Outcomes
modified Rankin Scale (mRS)
Time Frame: 90 (±14) days after treatment initiation
Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)
Secondary Outcomes
- Disability-weighted (or utility-weighted) mRS(90 (±14) days after treatment initiation)
- EQ-5D-5L(90 (±14) days after treatment initiation)
- Return to the pre-stroke mRS level(90 (±14) days after treatment initiation)
- Academic Medical Center - Linear Disability Scale (ALDS)(90 (±14) days after treatment initiation)