Treatment With Endovascular Intervention for STroke Patients With Existing Disability (TESTED)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke, Ischemic; Stroke, Acute
• Intervention / Treatment: Procedure: Endovascular Stroke Treatment; Other: Medical Management

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 Type: Observational
• Enrollment (Estimated): 1060

Contacts and Locations

• Study Contact: Name: Eva Mistry, MD; Phone Number: 513-558-1291; Email: mistryea@ucmail.uc.edu
• Study Contact Backup: Name: Naima Griffin; Phone Number: 513-558-0125; Email: griffna@ucmail.uc.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • HonorHealth
      • Principal Investigator: Ashu Jadhav, MD
      • Contact: Ashu Jadhav, MD
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Kaiser Permanente Los Angeles Medical Center
      • Contact: Shayandokht Taleb, MD
      • Principal Investigator: Shayandokht Taleb, MD
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California at Los Angeles
      • Contact: Jeffrey Saver, MD
      • Principal Investigator: Jeffrey Saver, MD
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Standford
      • Contact: Maarten Lansberg, MD
    • San Diego, California, United States, 92121
      • Recruiting
      • University of Cincinnati San Diego
      • Contact: Brett Meyer, MD
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Recruiting
      • Swedish Medical Center
      • Principal Investigator: Donald Frei, MD
      • Contact: Donald Frei, MD
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Hartford Health Hospital
      • Principal Investigator: Tapan Mehta, MD
      • Contact: Tapan Mehta, MD
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University
      • Contact: Adam DeHavenon, MD
      • Principal Investigator: Adam DeHavenon, MD
  • Florida
    • Miami, Florida, United States, 33125
      • Recruiting
      • University of Miami
      • Principal Investigator: Robert Starke, MD
      • Contact: Robert Starke, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Brian Howard, MD
      • Principal Investigator: Brian Howard, MD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: James Siegler, MD
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Isaac Josh Abecassis
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Principal Investigator: Mohamad AbdalKader
      • Contact: Mohamad AbdalKader, MD
  • Missouri
    • Saint Loius, Missouri, United States, 63110
      • Recruiting
      • Barnes Jewish Hospital
      • Contact: Charles Kircher, MD
  • New York
    • Brooklyn, New York, United States, 11220
      • Recruiting
      • New York University
      • Contact: Aaron Lord
      • Principal Investigator: Aaron Lord
    • New York, New York, United States, 10029
      • Recruiting
      • ICAHN School of Medicine at Mount Sinai
      • Principal Investigator: Shahram Majidi, MD
      • Contact: Shahram Majidi, MD
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University
      • Contact: Joshua Wiley, MD
      • Principal Investigator: Joshua Wiley, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Medical Center
      • Contact: Stacie Demel, DO, PhD
      • Principal Investigator: Stacie Demel, DO, PhD
  • Oregon
    • Portland, Oregon, United States, 97225
      • Recruiting
      • Providence St. Vincent Medical Center
      • Contact: Amit Kansara, MD
      • Principal Investigator: Amit Kansara, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh Medical Center
      • Contact: Raul Nogueira, MD
      • Principal Investigator: Raul Nogueira, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Recruiting
      • Baptist Memorial Hospital
      • Principal Investigator: Violiza Inoa, MD
      • Contact: Violiza Inoa, MD
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Deborah Kerrigan, MD
      • Principal Investigator: Deborah Kerrigan, MD
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • University of Texas at Austin
      • Contact: Hamidreza Saber, MD
      • Principal Investigator: Hamidreza Saber, MD
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • University of Washington
      • Principal Investigator: David Tirschwell, MD
      • Contact: David Tirschwell, MD
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University
      • Principal Investigator: Ansaar Rai, MD
      • Contact: Ansaar Rai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / 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

Procedure: Endovascular Stroke Treatment; 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; Other: Medical Management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	90 (±14) days after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	90 (±14) days after treatment initiation
Return to the pre-stroke mRS level	Returning to the pre-stroke mRS level post stroke	90 (±14) days after treatment initiation
EQ-5D-5L	Quality of life assessment scale with range: 0 (worst health) to 100 (best health)	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.	90 (±14) days after treatment initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	Montreal Cognitive Assessment (MoCA) (Note: MoCA range: 0-30, higher scores mean better outcome)	90 (±14) days after treatment initiation
Initial residence level or better time during first 90 days post-stroke	Number of days spend at the initial residence level or better during the first 90 days post-stroke	90 days after treatment initiation
Extended Thrombolysis in Cerebral Ischemia scale	The 7-point scale of eTICI is as follows: eTICI0 = 0% reperfusion; eTICI 1 = minimal flow past the occlusion but no perfusion ; eTICI2a = 1-49% reperfusion; eTICI2b50 = 50-66% reperfusion; eTICI2b67 = 67-89% reperfusion; eTICI2c = 90-99% reperfusion; eTICI3 = complete reperfusion	At the end of EVT procedure
Death		90 (±14) after treatment initiation
Symptomatic intracranial hemorrhage	Evaluate modified Heidelberg definition	24 (±6) hours
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)	At hospital discharge
Barthel Index Scale	Barthel Index range: 0-100, higher scores mean participant is independent	90 (±14) days after treatment initiation
Zarit's Burden Interview (ZBI)	ZBI is a measure of caregiving burden that includes a 22 item interview. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). We will use the 4 item version of the ZBI which has good correlation with the full version.	90 (±14) days after treatment initiation

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Patient-Centered Outcomes Research Institute; University of California, Los Angeles; Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: J Mocco, MD, ICAHN School of Medicine at Mount Sinai; Principal Investigator: Eva Mistry, MD, University of Cincinnati; Principal Investigator: Jeffrey Saver, MD, Ronald Reagan UCLA Medical Center; Principal Investigator: Heidi Sucharew, PhD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): April 15, 2028

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke; Professional Practice; Organization and Administration; Health Services Administration; Practice Management; Practice Management, Medical
• Other Study ID Numbers: 2023-0299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: One year after completing of the final analysis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No