Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Recruiting

• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute
• Interventions: Procedure: Endovascular Stroke Treatment; Other: Medical Management

• Registration Number: NCT05911568
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-22
• Status Verified: 2023-11
• Study Start: 2023-11-16
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2028-01-15
• Study Completion: 2028-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1060

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients with moderate-to-severe pre-stroke disability	Medical Management	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
Stroke patients with moderate-to-severe pre-stroke disability	Endovascular Stroke Treatment	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

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS)	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 Outcome Measures

Name	Time	Method
Disability-weighted (or utility-weighted) mRS	90 (±14) days after treatment initiation	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
EQ-5D-5L	90 (±14) days after treatment initiation	Quality of life assessment scale with range: 0 (worst health) to 100 (best health)
Return to the pre-stroke mRS level	90 (±14) days after treatment initiation	Returning to the pre-stroke mRS level post stroke
Academic Medical Center - Linear Disability Scale (ALDS)	90 (±14) days after treatment initiation	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.

Trial Locations

Locations (12)

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

HonorHealth; 🇺🇸 Phoenix, Arizona, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

Hartford Health Hospital; 🇺🇸 Hartford, Connecticut, United States

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States