What is the mechanism of action of this treatment?

Thrombectomy, a common treatment for ischemic stroke, involves the mechanical removal of a blood clot from a blocked artery in the brain to restore blood flow. This procedure is crucial because it can significantly reduce the risk of disability or death by quickly re-establishing circulation, thereby minimizing brain damage. The effectiveness of thrombectomy is time-sensitive, with faster intervention leading to better outcomes. This treatment is particularly beneficial for patients with large vessel occlusions, where it has been shown to improve recovery and reduce long-term neurological deficits.

What side effects are associated with this type of intervention?

Thrombectomy, a procedure used to mechanically remove a blood clot to restore blood flow in stroke patients, is generally considered safe but can have some side effects. Common side effects include bleeding at the puncture site, damage to the blood vessel, and, in rare cases, stroke or transient ischemic attack (TIA) due to dislodged clots. Other potential complications include infection, allergic reactions to contrast dye used during the procedure, and, though rare, vessel perforation. It is crucial to weigh these risks against the benefits of rapid restoration of blood flow to minimize stroke-related disability.

What prior FDA approvals exist?

The FDA has approved several devices for mechanical thrombectomy to treat ischemic stroke, which involves the removal of blood clots to restore blood flow. Notable devices include the Solitaire FR Revascularization Device and the Trevo ProVue Retriever. These devices are used in endovascular therapy (EVT) and have shown significant benefits in improving outcomes for patients with large vessel occlusions. Additionally, tissue plasminogen activator (tPA) is an FDA-approved drug used to dissolve clots in ischemic stroke, often administered before or in conjunction with mechanical thrombectomy.

What other types of research exist?

Promising novel alternatives to thrombectomy for stroke patients include: 1) Intravenous thrombolysis with newer agents such as tenecteplase, which may offer better outcomes compared to traditional alteplase. 2) Neuroprotective agents that aim to protect brain tissue during ischemic events, though these are still largely in experimental stages. 3) Endovascular techniques like aspiration thrombectomy, which may be used alone or in combination with mechanical thrombectomy. 4) Advanced imaging techniques to better select patients who may benefit from less invasive treatments. These alternatives are still under investigation and should be discussed with a healthcare provider to determine the best course of action.

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Procedure

Thrombectomy for Stroke (ESCAPE-MeVO Trial)

N/A

Waitlist Available

Led By Mayank Goyal, MD

Research Sponsored by Dr. Michael D Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disabling stroke defined as baseline National Institutes of Health Stroke Scale (NIHSS) score >5 at the time of randomization

Age ≥18 years at the date of randomization

Must not have

Patients living in a nursing home or requiring daily nursing care or assistance with activities of daily living

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Summary

This trial tests whether removing blood clots from medium-sized brain vessels helps stroke patients. The procedure uses a special device to pull out the clot and restore blood flow. It targets patients with sudden strokes caused by clots in medium-sized vessels.

Who is the study for?

This trial is for adults over 18 who've had a stroke caused by a medium-sized blood clot in the brain, and can start treatment within 12 hours. They must have certain symptoms and imaging results that show they could benefit from EVT. People with severe other illnesses, those already in another trial, or with specific poor health indicators like low ASPECTS scores aren't eligible.

What is being tested?

The ESCAPE-MeVO Trial is testing if adding endovascular thrombectomy (EVT) to standard medical care improves outcomes for patients with ischemic strokes due to medium vessel occlusions. Participants are randomly assigned to receive either just standard care or standard care plus EVT within 12 hours of symptom onset.

What are the potential side effects?

While not detailed here, potential side effects of EVT may include bleeding at the puncture site, damage to blood vessels, allergic reactions to contrast dye used during imaging procedures before EVT, and risk of further stroke.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a severe stroke with an NIHSS score over 5.

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I am 18 years old or older.

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I am eligible for an emergency procedure to remove a blood clot in my brain.

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I have a confirmed MeVO that can be treated with a procedure, as shown by special brain scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I live in a nursing home or need daily help with personal care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

modified Rankin Scale score (mRS)

Secondary study objectives

European Quality of LIfe Scale (EQ-5D-5L)

Mortality

National Institutes of Health Stroke Scale (NIHSS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: endovascular thrombectomyExperimental Treatment1 Intervention

All participants will receive the best standard of medical care according to modern acute stroke care guidelines. In the intervention/experimental arm, participants will be treated with endovascular thrombectomy with a Solitaire device (Medtronic) as the first line approach. The trial mandates that the first attempt is performed with a Solitaire X device (3mm, 4mm or 6mm diameter devices; Medtronic). The remaining treatment technique is left to the discretion of the treating neurointerventionalist. Secondary devices may be used if success is not achieved after use of the first device.

Group II: best medical carePlacebo Group1 Intervention

All patients will receive the best standard of medical care according to modern acute stroke care guidelines All patients including the ones in control arm will receive the best standard of medical care according to modern acute stroke care guidelines. The model will be the Canadian best practices guidelines for acute stroke care. These are very similar to the guidelines of the American Stroke Association and the European Stroke Organization. All participants are expected to be admitted to hospital as part of routine standard of care.It is expected that all participants will undergo a routine work-up for the mechanism of their stroke and be treated appropriately and definitively.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Thrombectomy, a common treatment for ischemic stroke, involves the mechanical removal of a blood clot from a blocked artery in the brain to restore blood flow. This procedure is crucial because it can significantly reduce the risk of disability or death by quickly re-establishing circulation, thereby minimizing brain damage. The effectiveness of thrombectomy is time-sensitive, with faster intervention leading to better outcomes. This treatment is particularly beneficial for patients with large vessel occlusions, where it has been shown to improve recovery and reduce long-term neurological deficits.

Mechanical Thrombectomy in Ischemic Stroke Patients With Alberta Stroke Program Early Computed Tomography Score 0-5.