Intra-arterial Therapy for Stroke

(TESLA Trial)

Recruiting at49 trial locations

Overseen by Albert J Yoo, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mercy Health Ohio

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.

Research Team

Osama O Zaidat, MD, MS

Principal Investigator

Mercy Health St. Vincent Medical Center

Albert J Yoo, MD, PhD

Principal Investigator

Texas Stroke Institute

Eligibility Criteria

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.

Inclusion Criteria

You are between 18 and 85 years old.

You have a score higher than 6 on a test that measures stroke severity.

You have symptoms that suggest you may be having a stroke.

Exclusion Criteria

Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test

Known severe allergy (more than a rash) to contrast media uncontrolled by medications

Your blood pressure is consistently very high and does not respond to treatment.

Treatment Details

Interventions

• IAT (Thrombectomy)

Trial Overview 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.

Participant Groups

Group I: Intra-arterial Therapy Experimental Treatment 1 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 Management Active Control 1 Intervention

Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.

Who Is Running the Clinical Trial?

Mercy Health Ohio

Lead Sponsor

Trials

15

Recruited

1,600+