What side effects are associated with this type of intervention?

Mechanical thrombectomy, a common treatment for cerebral ischemia, primarily carries risks of intracranial hemorrhage, vessel perforation, and arterial dissection. Other potential side effects include embolization to new territories, access site complications like hematoma or pseudoaneurysm, and rare instances of infection.

What prior FDA approvals exist?

The FDA has approved several mechanical thrombectomy devices for the treatment of acute ischemic stroke, which involve the physical removal of a clot to restore blood flow. These include stent retrievers and aspiration systems. Additionally, intravenous thrombolytic therapy with tissue plasminogen activator (tPA) has been a key treatment for acute ischemic stroke, although it is a pharmacological approach rather than a mechanical one.

What other types of research exist?

The provided context does not mention specific novel alternatives to Immediate Mechanical Thrombectomy (iMT) for cerebral ischemia patients. However, ongoing research and clinical trials are continuously exploring new therapies. Patients should consult with their healthcare providers to discuss the latest advancements and personalized treatment options.

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Thrombectomy Device

Endovascular Therapy for Ischemic Stroke (ENDOLOW Trial)

Phase 2 & 3

Recruiting

Led By Raul G Nogueira, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Patients eligible for intravenous rt-PA should receive this therapy as soon as possible and no later than 4.5 hours from symptom onset

Age 18 years or older

Must not have

Premorbid disability (mRS ≥3)

Known acute symptomatic COVID-19 infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if removing a blood clot from the brain right after a stroke helps patients with mild symptoms recover better than usual care. It focuses on patients with large clots and mild symptoms shortly after their stroke.

Who is the study for?

This trial is for adults over 18 with a recent ischemic stroke, showing specific signs of brain artery blockage but only mild stroke symptoms. They must have received clot-dissolving treatment within 4.5 hours if eligible. Excluded are those with severe strokes, bleeding in the brain, certain arterial diseases, pre-stroke disabilities, or conditions conflicting with the study.

What is being tested?

The study compares immediate mechanical removal of the blood clot using EmboTrap (iMT) versus initial standard medical care (iMM) in patients who had a mild stroke due to major artery blockage in the brain and arrived at the hospital within 8 hours.

What are the potential side effects?

Possible side effects from iMT include risks associated with endovascular procedures such as damage to blood vessels, bleeding in the brain, potential allergic reactions to materials used during thrombectomy or contrast agents.

Eligibility Criteria

Inclusion Criteria

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

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I am within 4.5 hours of my stroke symptoms starting.

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I am 18 years old or older.

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I had a mild stroke with minor symptoms.

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I have a blockage in a major brain artery shown on a scan.

Exclusion Criteria

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

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I had significant disability before my current illness.

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I currently have symptoms of COVID-19.

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My kidney function is impaired with creatinine levels above 3.0 mg/dL.

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I cannot be enrolled in the study within 8 hours of feeling normal.

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I need a machine to help me breathe before joining the study.

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I might have an infection in my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (Ordinal Shift Analysis).

Therapeutic procedure

Symptomatic intracranial hemorrhage (sICH) within 36 hours comparing the two treatment arms

Secondary study objectives

Health-related quality of life EQ-5D score comparing the two treatment arms

Infarct volume

Instrumental Activities of Daily Living (IADL)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate mechanical thrombectomy(iMT)Experimental Treatment1 Intervention

Treatment initiation within 8 hours of symptom onset. Arterial puncture and revascularization will be performed using EmboTrap II Retriever. The procedure will be completed within two hours of arterial access.

Group II: Initial medical management (iMM)Active Control1 Intervention

Standard medical therapy based on current AHA (American Heart Association) guidelines. Rescue mechanical thrombectomy (rMT) is allowed for patients initially assigned to iMM if they suffer major neurological worsening that clearly requires an intra-arterial intervention in the judgment of the treating team.

0 / 10Eligibility 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

The most common treatments for cerebral ischemia include intravenous thrombolysis and mechanical thrombectomy. Intravenous thrombolysis involves the administration of tissue plasminogen activator (tPA) to dissolve the blood clot obstructing the cerebral artery, thereby restoring blood flow. Mechanical thrombectomy, on the other hand, involves the physical removal of the clot using specialized devices inserted through a catheter. This method is particularly effective for large vessel occlusions and can be performed up to 24 hours after symptom onset. These treatments are crucial for cerebral ischemia patients as they aim to quickly restore blood flow to the affected brain regions, minimizing brain damage and improving functional outcomes.

Acute ischemic stroke: emergency department management after the 3-hour window.Acute Ischemic Stroke Treatment in Infective Endocarditis: Systematic Review.Acute stroke intervention: a systematic review.