← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 hours
Awards & highlights

ENDOLOW Trial Summary

This trial will test whether patients with a certain type of stroke do better with a medical procedure than with initial medical management.

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.Check my eligibility
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.See study design
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.

ENDOLOW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am within 4.5 hours of my stroke symptoms starting.
Select...
I am 18 years old or older.
Select...
I had a mild stroke with minor symptoms.
Select...
I have a blockage in a major brain artery shown on a scan.

ENDOLOW Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Health-related quality of life EQ-5D score comparing the two treatment arms
Infarct volume
Instrumental Activities of Daily Living (IADL)
+8 more

ENDOLOW 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.

Find a Location

Who is running the clinical trial?

University of CalgaryOTHER
795 Previous Clinical Trials
874,379 Total Patients Enrolled
Emory UniversityLead Sponsor
1,645 Previous Clinical Trials
2,564,350 Total Patients Enrolled
University of CincinnatiOTHER
430 Previous Clinical Trials
634,291 Total Patients Enrolled

Media Library

Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device (Thrombectomy Device) Clinical Trial Eligibility Overview. Trial Name: NCT04167527 — Phase 2 & 3
Cerebral Ischemia Research Study Groups: Immediate mechanical thrombectomy(iMT), Initial medical management (iMM)
Cerebral Ischemia Clinical Trial 2023: Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device Highlights & Side Effects. Trial Name: NCT04167527 — Phase 2 & 3
Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device (Thrombectomy Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167527 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators still signing up new participants for this experiment?

"The trial, as indicated by recent activity on clinicaltrials.gov, is looking for more participants. It was originally posted on September 5th, 2020 and updated on the 13th of September in 2022."

Answered by AI

Who else is applying?

What site did they apply to?
JFK Neurosciences Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~24 spots leftby Dec 2024