Treatment With Endovascular Intervention for STroke Patients With Existing Disability (TESTED)
Sponsor: Icahn School of Medicine at Mount Sinai
Listed as NCT05911568, this observational or N/A phase trial focuses on Stroke and Stroke, Acute and remains actively recruiting participants. Sponsored by Icahn School of Medicine at Mount Sinai, it has been updated 9 times since 2023, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
9 versions recorded-
Apr 16, 2026 — Present [daily]
Recruiting
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Feb 2026 — Apr 2026 [monthly]
Recruiting
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Oct 2025 — Feb 2026 [monthly]
Recruiting
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Jun 2025 — Oct 2025 [monthly]
Recruiting
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Sep 2024 — Jun 2025 [monthly]
Recruiting
▶ Show 4 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Recruiting
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Dec 2023 — Jul 2024 [monthly]
Recruiting
Status: Not Yet Recruiting → Recruiting
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Aug 2023 — Dec 2023 [monthly]
Not Yet Recruiting
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Jul 2023 — Aug 2023 [monthly]
Not Yet Recruiting
First recorded
Eligibility 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.
Contact Information
- Icahn School of Medicine at Mount Sinai
- Patient-Centered Outcomes Research Institute
- University of California, Los Angeles
- University of Cincinnati
For direct contact, visit the study record on ClinicalTrials.gov .