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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
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 96 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 hours
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 moreENDOLOW 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
792 Previous Clinical Trials
868,954 Total Patients Enrolled
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,332 Total Patients Enrolled
University of CincinnatiOTHER
428 Previous Clinical Trials
634,186 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher.You have a low platelet count, less than 100,000 per microliter of blood.Your blood sugar levels are either too low (less than 50 mg/dL) or too high (more than 400 mg/dL).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.I had significant disability before my current illness.There is strong evidence of a serious problem with the arteries in your brain.I have a health issue that makes endovascular procedures too risky for me.I had seizures when my stroke started, making it hard to assess my initial stroke severity.You have any signs of bleeding inside your brain on a baseline CT or MRI scan.I currently have symptoms of COVID-19.My kidney function is impaired with creatinine levels above 3.0 mg/dL.I have a blockage in a major brain artery shown on a scan.I cannot be enrolled in the study within 8 hours of feeling normal.The local doctor thinks that trying to open up blocked blood vessels wouldn't help based on the pictures of your insides.I need a machine to help me breathe before joining the study.I might have an infection in my heart.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate mechanical thrombectomy(iMT)
- Group 2: Initial medical management (iMM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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