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StrokeTESTEDNCT05911568

Treatment With Endovascular Intervention for STroke Patients With Existing Disability

An observational study of Stroke and Stroke, Acute, run by University of Cincinnati at 35 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Stroke, Acute, Stroke, Ischemic
What is being tested?
Endovascular Stroke Treatment and Medical Management
How many people
1,060 participants
Where
35 sitesUnited States
Study dates
16 Nov 2023to 15 Apr 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

35 sites in 1 country. Contact the study team or a site near you to ask about taking part.

35 sites in 1 country

United States35 sites, 33 recruiting
  • Emory University

    Atlanta, Georgia, 30322

    Brian Howard, MD

    Brian Howard, MD

    Recruiting
  • University of Texas at Austin

    Austin, Texas, 78712

    Hamidreza Saber, MD

    Hamidreza Saber, MD

    Recruiting
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Toby Gropen, MD

    Toby Gropen, MD

    Recruiting
  • Boston Medical Center

    Boston, Massachusetts, 02118

    Mohamad AbdalKader, MD

    Mohamad AbdalKader

    Recruiting
  • New York University

    Brooklyn, New York, 11220

    Aaron Lord

    Aaron Lord

    Recruiting
  • University of Virginia

    Charlottesville, Virginia, 22904

    Cesarina Thohan

    Cesarina Thohan, MD

    Recruiting
  • University of Chicago

    Chicago, Illinois, 60637

    James Siegler, MD

    Recruiting
  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Stacie Demel, DO, PhD

    Stacie Demel, DO, PhD

    Recruiting
  • TriHealth Good Samaritan Hospital

    Cincinnati, Ohio, 45220

    Faraze Niazi, MD

    Faraze Niazi, MD

    Recruiting
  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Jenny Tsai, MD

    Jenny Tsai, MD

    Recruiting
  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Vivien Lee, MD

    Vivien Lee, MD

    Recruiting
  • Swedish Medical Center

    Englewood, Colorado, 80113

    Withdrawn
  • Hartford Health Hospital

    Hartford, Connecticut, 06106

    Tapan Mehta, MD

    Tapan Mehta, MD

    Recruiting
  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

    Tanu Garg, MD

    Tanu Garg, MD

    Recruiting
  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Shayandokht Taleb, MD

    Shayandokht Taleb, MD

    Recruiting
  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Benedict Pereira, MD

    Benedict Pereira, MD

    Recruiting
  • University of California at Los Angeles

    Los Angeles, California, 90095

    Jeffrey Saver, MD

    Jeffrey Saver, MD

    Recruiting
  • University of Louisville

    Louisville, Kentucky, 40202

    Isaac Josh Abecassis

    Recruiting
  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

    Violiza Inoa, MD

    Violiza Inoa, MD

    Recruiting
  • University of Miami

    Miami, Florida, 33125

    Robert Starke, MD

    Robert Starke, MD

    Recruiting
  • Baptist Hospital of Miami

    Miami, Florida, 33176

    Felipe De Los Rios La Rosa, MD

    Felipe De Los Rios La Rosa, MD

    Recruiting
  • West Virginia University

    Morgantown, West Virginia, 26506

    Terminated
  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Deborah Kerrigan, MD

    Deborah Kerrigan, MD

    Recruiting
  • Yale University

    New Haven, Connecticut, 06510

    Adam DeHavenon, MD

    Adam DeHavenon, MD

    Recruiting
  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Shahram Majidi, MD

    Shahram Majidi, MD

    Recruiting
  • Columbia University

    New York, New York, 10032

    Joshua Wiley, MD

    Joshua Wiley, MD

    Recruiting
  • Stanford University

    Palo Alto, California, 94305

    Maarten Lansberg, MD

    Recruiting
  • HonorHealth

    Phoenix, Arizona, 85013

    Ashu Jadhav, MD

    Ashu Jadhav, MD

    Recruiting
  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Raul Nogueira, MD

    Raul Nogueira, MD

    Recruiting
  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

    Amit Kansara, MD

    Amit Kansara, MD

    Recruiting
  • Barnes Jewish Hospital

    Saint Loius, Missouri, 63110

    Charles Kircher, MD

    Recruiting
  • University of Utah

    Salt Lake City, Utah, 84112

    Jennifer Majersik, MD

    Jennifer Majersik, MD

    Recruiting
  • University of California San Diego

    San Diego, California, 92121

    Brett Meyer, MD

    Recruiting
  • University of Washington

    Seattle, Washington, 98104

    David Tirschwell, MD

    David Tirschwell, MD

    Recruiting
  • Ascension St. John

    Tulsa, Oklahoma, 74104

    Rahul Rahangdale

    Rahul Rahangdale, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Endovascular Stroke Treatment, Medical Management
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular Stroke TreatmentProcedure or surgery

    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

  • Medical ManagementOther

    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.

Study groups in NCT05911568
Study groupRoleWhat they receive
Stroke patients with moderate-to-severe pre-stroke disabilityPatients 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
Receives: Procedure: Endovascular Stroke Treatment; Other: Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 90 (±14) days after treatment initiation

Secondary outcomes (4)
  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

    Measured: 90 (±14) days after treatment initiation

  2. Return to the pre-stroke mRS level

    Returning to the pre-stroke mRS level post stroke

    Measured: 90 (±14) days after treatment initiation

  3. EQ-5D-5L

    Quality of life assessment scale with range: 0 (worst health) to 100 (best health)

    Measured: 90 (±14) days after treatment initiation

  4. 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.

    Measured: 90 (±14) days after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start16 Nov 2023
  3. Primary completion15 Jan 2028 (estimated)
  4. Study completion15 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,060 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05911568
Sponsor's protocol ID
2023-0299
Acronym
TESTED
Status last verified
Aug 2026
First submitted
9 Jun 2023
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Stroke, Acute, run by University of Cincinnati at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Mistry, MD (513-558-1291, mistryea@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale (mRS) (time frame: 90 (±14) days after treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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