Endovascular Therapy for Ischemic Stroke
(ENDOLOW Trial)

Recruiting in Palo Alto (17 mi)

+34 other locations

Overseen byRaul G Nogueira, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Emory University

No Placebo Group

Prior Safety Data

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.

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 am 18 years old or older.

I had a mild stroke with minor symptoms.

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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.

See 16 more

Treatment Details

Interventions

Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device (Thrombectomy Device)
Immediate mechanical thrombectomy(iMT) using EmboTrap Revascularization Device (Thrombectomy Device)
Initial medical management (iMM) (Combination Product)

Trial OverviewThe 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

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.