Endovascular Intervention for Stroke

(TESTED Trial)

Recruiting at 17 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether endovascular thrombectomy (EVT) is more effective or riskier than standard medical care for individuals who have experienced an ischemic stroke. The focus is on patients who had moderate-to-severe disabilities before their stroke and now have a blockage in a large brain blood vessel. It suits those who have lived with this level of disability for at least three months and have experienced an acute stroke within the last 24 hours. The study compares outcomes between those receiving EVT and those who do not. Participants will help researchers identify which treatment option might offer better recovery or fewer complications. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that endovascular intervention is safe for stroke patients with moderate-to-severe pre-stroke disability?

Research has shown that endovascular thrombectomy (EVT) is generally safe for treating blockages in large brain vessels during a stroke. One study found EVT to be as safe as medication alone, with patients experiencing no more side effects than those who only took medicine. Another study examined EVT performed more than 24 hours after a stroke and found that, although the benefits were less clear, the safety remained good.

In simpler terms, EVT appears safe, even when performed later than usual. This suggests that the procedure is relatively safe for individuals with severe strokes. However, like any treatment, there are risks, and results can vary. These factors are important to consider when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of endovascular intervention for stroke patients who already have moderate-to-severe pre-stroke disabilities. Unlike the standard of care, which typically focuses on stroke patients without prior disabilities, this approach targets patients with a pre-existing modified Rankin scale score of 3 or 4, offering a new avenue for treatment. By addressing anterior circulation large vessel occlusions within 24 hours of onset, this method could significantly improve outcomes for a group often overlooked in stroke management. This trial aims to broaden the understanding of stroke treatment efficacy in a more diverse patient population.

What evidence suggests that endovascular intervention is effective for ischemic stroke?

Studies have shown that endovascular thrombectomy (EVT), the treatment under study in this trial, effectively aids recovery from strokes caused by large blood vessel blockages. Research indicates that EVT reduces disability more effectively than medication alone, especially when performed soon after the stroke occurs. Although some studies show mixed results if performed after 24 hours, most agree that EVT is beneficial when used promptly. Overall, EVT has greatly improved the treatment of strokes caused by large vessel blockages. ^{3 4 5 6 7}

Who Is on the Research Team?

Eva Mistry, MD

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

Heidi Sucharew, PhD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Endovascular Intervention

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12333737/

Endovascular therapy in large vessel occlusion stroke These interventions have significantly improved functional outcomes when performed within appropriate time windows. However, despite its ...

2. ahajournals.org ahajournals.org/doi/10.1161/SVIN.124.001581

Endovascular Therapy in Patients With Acute Ischemic ... Endovascular therapy is highly effective in improving functional outcomes in patients with acute ischemic stroke from large vessel occlusion ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025002992

Efficacy and Safety of Endovascular Thrombectomy for ... We performed a systematic review and meta-analysis to examine the outcomes of EVT in patients with acute ischemic stroke beyond 24 hours from onset.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2214403

Trial of Endovascular Thrombectomy for Large Ischemic ... Endovascular thrombectomy has been shown to be more effective in reducing disability than medical therapy alone in selected patients with ischemic stroke.

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000214015

Endovascular Treatment in Acute Ischemic Stroke Due to ... The present meta-analysis demonstrates that EVT does not significantly improve excellent or good functional outcomes at 3 months compared with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10574302/

Clinical and Safety Outcomes of Endovascular Therapy 6 ... Endovascular therapy (EVT) is considered a highly effective and safe approach for large vessel occlusion (LVO) of the anterior circulation in acute ischemic ...

7. ahajournals.org ahajournals.org/doi/10.1161/SVIN.124.001609?doi=10.1161/SVIN.124.001609

Results From the TRACK‐LVO Late Multicenter Cohort The efficacy and safety of endovascular thrombectomy (EVT) performed beyond 24 hours from the last known well remain uncertain. This study aims ...