Endovascular Therapy for Ischemic Stroke

(ENDOLOW Trial)

Recruiting at 34 trial locations

Overseen By Alex Hall, MS, RN, CEN

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Emory University

Disqualifiers: Intracranial hemorrhage, Seizures, Renal failure, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate intervention

143 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are eligible for intravenous rt-PA, you should receive it as soon as possible, which may affect other medications you are taking.

What data supports the effectiveness of this treatment for ischemic stroke?

Research shows that the EmboTrap device, used in mechanical thrombectomy (a procedure to remove blood clots from blood vessels), is effective in restoring blood flow and improving outcomes in patients with acute ischemic stroke. This device is designed to help retrieve clots more efficiently, which is crucial for treating strokes caused by blocked blood vessels. ^{1 2 3 4 5}

Is the EmboTrap device safe for use in humans?

Research on the EmboTrap device for treating ischemic stroke suggests it is generally safe, as studies describe its use in restoring blood flow in patients without highlighting significant safety concerns. ^{2 3 4 5 6}

How is the treatment using the EmboTrap device for ischemic stroke different from other treatments?

The EmboTrap device is unique because it is a novel stent retriever with a dual-layer design that helps effectively capture and remove blood clots, restoring blood flow quickly in patients with acute ischemic stroke. This innovative feature distinguishes it from other mechanical thrombectomy devices. ^{2 3 4 5 7}

Research Team

Raul G Nogueira, MD

Principal Investigator

Emory University

Eligibility Criteria

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.

Inclusion Criteria

I am within 4.5 hours of my stroke symptoms starting.

I had a mild stroke with minor symptoms.

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

Exclusion Criteria

History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

Site investigator does not have equipoise towards the ideal treatment concept (thrombectomy vs. best medical management)

You have a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Immediate mechanical thrombectomy (iMT) or initial medical management (iMM) initiated within 8 hours of symptom onset

Immediate intervention

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of intracerebral hemorrhage and other outcomes

90 days

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device
• Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device
• Initial medical management (iMM)

Trial Overview 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.

Participant Groups

Group I: Immediate mechanical thrombectomy(iMT) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

University of Cincinnati

Collaborator

Trials

442

Recruited

639,000+

Heidelberg University

Collaborator

Trials

403

Recruited

277,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Findings from Research

The EmboTrap device achieved a high recanalization success rate of 90% in 80 patients with acute ischemic stroke, indicating its efficacy in restoring blood flow in large vessel occlusions.

The procedure was found to be safe, with only 6% of patients experiencing distal emboli and a low rate of complications, including 6% symptomatic intracranial hemorrhage, suggesting that EmboTrap is a reliable option for stroke treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter initial experience with the EmboTrap device in acute anterior ischemic stroke. Bourcier, R., Abed, D., Piotin, M., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Thrombectomy Using the EmboTrap II Device in Late Treatment Patients in the Real-World Setting. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Thrombectomy Using the EmboTrap Clot-Retrieving Device for the Treatment of Acute Ischemic Stroke: A Glimpse of Clinical Evidence. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Real-world outcomes associated with the use of the EmboTrap revascularization device for ischemic stroke in the United States. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Multicenter initial experience with the EmboTrap device in acute anterior ischemic stroke. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Developing new quantitative CT image markers to predict prognosis of acute ischemic stroke patients. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

First-In-Man Procedural Experience with the Novel EmboTrap® Revascularization Device for the Treatment of Ischemic Stroke-A European Multicenter Series. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap). [2019]