Treatment With Endovascular Intervention for STroke Patients With Existing Disability

(TESTED Trial)

Recruiting at 11 trial locations

Overseen By Naima Griffin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Cincinnati

Disqualifiers: Terminal cancer, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 90

Duration: Up to 24 hours from last known well

1060 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eva Mistry, MD

Principal Investigator

University of Cincinnati

Heidi Sucharew, PhD

Principal Investigator

University of Cincinnati

Jeffrey Saver, MD

Principal Investigator

Ronald Reagan UCLA Medical Center

J Mocco, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either endovascular thrombectomy (EVT) or multimodal medical management (MMM) for ischemic stroke

Up to 24 hours from last known well

In-hospital procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments like the modified Rankin Scale and quality of life measures

90 days

Multiple assessments over 90 days

Treatment Details

Participant Groups

Group I: Stroke patients with moderate-to-severe pre-stroke disability Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of Cincinnati

Lead Sponsor

Trials

442

Recruited

639,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+