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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
- 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
- Withdrawn
Swedish Medical Center
Englewood, Colorado, 80113
- Recruiting
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
- Terminated
West Virginia University
Morgantown, West Virginia, 26506
- Recruiting
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
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.
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic
- 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 group | Role | What they receive |
|---|---|---|
| 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 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.
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)
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
Return to the pre-stroke mRS level
Returning to the pre-stroke mRS level post stroke
Measured: 90 (±14) days after treatment initiation
EQ-5D-5L
Quality of life assessment scale with range: 0 (worst health) to 100 (best health)
Measured: 90 (±14) days after treatment initiation
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.
- First posted22 Jun 2023
- Study start16 Nov 2023
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of California, Los Angeles, Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Eva A. Mistry, University of Cincinnati
- Investigators
- Eva Mistry, MD, Principal investigator, University of CincinnatiJeffrey Saver, MD, Principal investigator, Ronald Reagan UCLA Medical CenterJ Mocco, MD, Principal investigator, Weill Medical College of Cornell UniversityHeidi Sucharew, PhD, Principal investigator, University of Cincinnati
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Endovascular Intervention for STroke Patients With Existing Disability
- ClinicalTrials.gov ID
- NCT05911568
- Acronym / sponsor ID
- TESTED / 2023-0299
- Conditions
- Stroke, Stroke, Acute, Stroke, Ischemic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,060 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, University of California, Los Angeles, Icahn School of Medicine at Mount Sinai
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients with moderate-to-severe pre-stroke disability | – | Procedure: Endovascular Stroke Treatment, Other: Medical ManagementPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Stroke TreatmentPatients 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 | Procedure or surgery | Stroke patients with moderate-to-severe pre-stroke disability |
| Medical ManagementPatients 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. | Other | Stroke patients with moderate-to-severe pre-stroke disability |
Primary outcome
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)
4 secondary outcomes
Disability-weighted (or utility-weighted) mRS
Time frame: 90 (±14) days after treatment initiation
Return to the pre-stroke mRS level
Time frame: 90 (±14) days after treatment initiation
EQ-5D-5L
Time frame: 90 (±14) days after treatment initiation
Academic Medical Center - Linear Disability Scale (ALDS)
Time frame: 90 (±14) days after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva Mistry, MD principal investigator
University of Cincinnati
Jeffrey Saver, MD principal investigator
Ronald Reagan UCLA Medical Center
J Mocco, MD principal investigator
Weill Medical College of Cornell University
35 sites in 1 country: see every site and its status.
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.