Endovascular Therapy for Ischemic Stroke

(ENDOLOW Trial)

Not currently recruiting at 36 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether people with ischemic stroke benefit more from immediate mechanical thrombectomy (iMT) or standard medical treatment. The trial will compare two groups: one receiving immediate iMT, a procedure that removes brain blockages using devices like the EmboTrap II Revascularization Device, and the other receiving standard medical care. Individuals with a stroke caused by a large blood vessel blockage and mild symptoms may qualify. The goal is to identify which treatment leads to better recovery after 90 days. As a Phase 2, Phase 3 trial, this study assesses the treatment's effectiveness in an initial group and evaluates its efficacy in the final step before FDA approval, allowing participants to contribute to potentially groundbreaking stroke treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the EmboTrap and EmboTrap II devices are generally well-tolerated in patients with acute ischemic stroke, which occurs when blood flow to the brain is blocked. Research indicates these devices effectively restore blood flow. Patients have achieved high rates of functional independence, allowing them to live more normal lives after treatment.

Initial experiences with the EmboTrap II demonstrated its technical safety for performing thrombectomies, a procedure to remove blockages from blood vessels. Similarly, real-world data for the EmboTrap suggests positive outcomes with minimal serious side effects.

In summary, both EmboTrap and EmboTrap II devices are considered safe based on current studies and show promise in aiding patient recovery after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for ischemic stroke because they may offer faster and more effective interventions compared to standard medical therapies like clot-busting drugs or delayed mechanical thrombectomy. The immediate mechanical thrombectomy (iMT) using the EmboTrap II Revascularization Device is performed within eight hours of symptom onset, potentially restoring blood flow to the brain more quickly and reducing the risk of long-term damage. This device is designed to efficiently capture and remove blood clots, offering a more targeted and rapid approach. Additionally, the option for rescue mechanical thrombectomy (rMT) for those initially on medical management ensures that patients have a backup plan if their condition worsens, combining immediate medical intervention with the flexibility to escalate care as needed.

What evidence suggests that immediate mechanical thrombectomy using the EmboTrap devices is effective for ischemic stroke?

Studies have shown that EmboTrap devices for mechanical thrombectomy can effectively treat ischemic strokes. In this trial, participants may receive immediate mechanical thrombectomy (iMT) using either the EmboTrap II Revascularization Device or the EmboTrap Revascularization Device. The EmboTrap device has successfully restored blood flow and helped stroke patients regain independence. One study reported a 90% success rate in opening blocked blood vessels, with good safety results. Another analysis found that patients treated with the EmboTrap had better recovery outcomes compared to other treatments. These findings suggest that EmboTrap devices could be promising for patients with large blocked blood vessels and mild strokes. ^{2 3 4 5 6}

Who Is on the Research Team?

Raul G Nogueira, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8115375/

Early Postmarket Results with EmboTrap II Stent Retriever ... EmboTrap II is a novel stent retriever with a dual-layer design and distal mesh designed for acute ischemic stroke emergent large-vessel occlusions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02488915

Analysis of Revascularization in Ischemic Stroke With ... The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated ...

3. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.117.020125

Primary Results of the Multicenter ARISE II Study (Analysis ... The EmboTrap stent-retriever mechanical thrombectomy device demonstrated high rates of substantial reperfusion and functional independence in patients with ...

4. becarispublishing.com becarispublishing.com/doi/10.57264/cer-2023-0001

MASTRO I: Meta-Analysis and Systematic Review of ... The results of our Systematic Review/Meta-Analysis suggest that EmboTrap may be associated with significantly improved functional outcomes compared with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04167527

Endovascular Therapy for Low NIHSS Ischemic Strokes Experience with immediate mechanical thrombectomy (iMT) in the LVO mild stroke target population is limited. This study will test the hypothesis that patients ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34750107/

Real-world outcomes associated with the use of ... This is the first study in the US to report real-world outcomes sourced by retrospective database analysis among patients with AIS undergoing MT using the ...