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Thrombectomy
Intra-arterial Therapy for Stroke (TESLA Trial)
N/A
Waitlist Available
Led By Albert J Yoo, MD, PhD
Research Sponsored by Mercy Health Ohio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days post randomization
Awards & highlights
TESLA Trial Summary
This trial is testing a new treatment for strokes. It will adaptively enrich to better define the upper limit of infarct volume for treatment eligibility and assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.
Who is the study for?
The TESLA Trial is for adults aged 18-85 with acute ischemic stroke, showing specific symptoms and scoring over 6 on the NIHSS. They must have a blockage in certain arteries of the brain, be able to join within 24 hours of symptom onset, and have had good health before the stroke. Pregnant women or those with severe allergies to contrast media, uncontrolled high blood pressure, certain CT scan findings that suggest risk are excluded.Check my eligibility
What is being tested?
This trial tests Intra-arterial Therapy (IAT) against standard medical management in patients with moderate to large strokes as seen on imaging. It aims to find out if IAT can help these patients recover better than usual treatments alone and identify which patient groups might benefit most from this approach.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to contrast media used during IAT such as nausea or rash; risks associated with endovascular procedures like bleeding or vessel damage; and typical stroke complications including weakness or speech difficulties.
TESLA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Utility-weighted 90-day Modified Rankin Score
TESLA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intra-arterial TherapyExperimental Treatment1 Intervention
For patients randomized to the intra-arterial therapy arm, sites will use local protocols for femoral access, sedation, heparin infusion, monitoring, etc. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the IFU.
Group II: Medical ManagementActive Control1 Intervention
Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
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Who is running the clinical trial?
Mercy Health OhioLead Sponsor
14 Previous Clinical Trials
1,305 Total Patients Enrolled
1 Trials studying Ischemic Stroke
404 Patients Enrolled for Ischemic Stroke
Albert J Yoo, MD, PhDPrincipal InvestigatorTexas Stroke Institute
Osama O Zaidat, MD, MSPrincipal InvestigatorMercy Health St. Vincent Medical Center
4 Previous Clinical Trials
1,054 Total Patients Enrolled
2 Trials studying Ischemic Stroke
904 Patients Enrolled for Ischemic Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 18 and 85 years old.You have a score higher than 6 on a test that measures stroke severity.Your blood pressure is consistently very high and does not respond to treatment.You have symptoms that suggest you may be having a stroke.There is clear evidence of a blockage in a certain part of the brain's blood vessels.You had a score of 0-1 on a test of your ability to function before your stroke.Your brain scan shows a moderate to large area of damage from a stroke.Criterion: You have certain conditions seen on a CT scan, a specific type of stroke, tumors in the brain, blood clotting issues, or other serious health problems that could make it unsafe for you to have a certain type of procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Medical Management
- Group 2: Intra-arterial Therapy
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.
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Feinstein Institute for Medical Research, Northwell
What portion of applicants met pre-screening criteria?
Met criteria
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