The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke (TESLA)

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Procedure: Intra-arterial Therapy

Detailed Description

Prospective, randomized, open-label, blinded endpoint study. Patients presenting with symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta Stroke Program Early CT score [NCCT ASPECTS] 2-5 in the anterior circulation will be assigned to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Each treated patient will be followed and assessed for 3 months after randomization.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center for Clinical Research
  • California
    • Los Angeles, California, United States, 90017
      • PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
    • Pomona, California, United States, 91767
      • Pomona Valley Hospital Medical Center
    • Sacramento, California, United States, 95816
      • Sutter Institute for Medical Research
    • San Francisco, California, United States, 94107
      • California Pacific Medical Center & Mills Peninsula Medical Center
    • Thousand Oaks, California, United States, 91360
      • Los Robles Hospital and Medical Center
    • Torrance, California, United States, 90503
      • Providence Saint John's Health Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital Inc.
    • Coral Gables, Florida, United States, 33146
      • University of Miami
    • Delray Beach, Florida, United States, 33484
      • Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
    • Orlando, Florida, United States, 32806
      • Orlando Health Inc.
    • Tampa, Florida, United States, 33612
      • University Of South Florida
  • Georgia
    • Marietta, Georgia, United States, 30062
      • Wellstar Health System, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
    • Evanston, Illinois, United States, 60208
      • Northwestern University
    • Lisle, Illinois, United States, 60532
      • AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Medical Group
    • Munster, Indiana, United States, 46321
      • Munster Medical Research Foundation
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Healthcare System Inc. d/b/a Baptist Health Lexington
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • LSU Health Sciences Center at Shreveport
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • McLaren Health Care Corporation
    • Kalamazoo, Michigan, United States, 49008
      • Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • SSM Health DePaul Hospital
    • Saint Louis, Missouri, United States, 63103
      • Saint Louis University
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • The Community Hospital Group Inc. t/a JFK Medical Center
    • Piscataway, New Jersey, United States, 08854
      • Rutgers The State University
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo
    • Manhasset, New York, United States, 11030
      • Feinstein Institute for Medical Research, Northwell
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
    • Toledo, Ohio, United States, 43608
      • Mercy Health St. Vincent Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • El Paso, Texas, United States, 79424
      • Texas Tech University of Health Sciences
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Plano, Texas, United States, 75075
      • Texas Stroke Institute
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University
  • Washington
    • Renton, Washington, United States, 98055
      • Valley Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 to 85 years of age
2. Presenting with symptoms consistent with an acute ischemic stroke
3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment
4. NIHSS score >6 at the time of randomization
5. Ability to randomize within 24 hours of stroke onset
6. Pre-stroke mRS score 0-1
7. Ability to obtain signed informed consent

Imaging evidence of moderate-large infarct defined as:

1. NCCT ASPECTS 2-5

Exclusion Criteria:

1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications
3. Refractory hypertension (defined as persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg)

4. CT evidence of the following conditions:

   • Midline shift or herniation
   • Evidence of intracranial hemorrhage
   • Mass effect with effacement of the ventricles
5. Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
6. Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
7. Rapidly improving neurological status prior to randomization to NIHSS <6
8. Bilateral strokes or multiple intracranial occlusions
9. Intracranial tumors
10. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
11. Baseline platelet count <30,000 per microliter (µl)
12. Life expectancy less than 90 days prior to stroke onset
13. Participation in another randomized clinical trial that could confound the evaluation of the study
14. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Medical Management; Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
Experimental: Intra-arterial Therapy; 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.	Procedure: Intra-arterial Therapy; Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.; Other Names: Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility-weighted 90-day Modified Rankin Score	Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death. 0 = No symptoms at all.; = No significant disability despite symptoms; able to carry out all usual duties and activities.; = Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.; = Moderate disability requiring some help, but able to walk without assistance.; = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.; = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.; = Death	90 days post randomization

Collaborators and Investigators

• Sponsor: Mercy Health Ohio
• Investigators: Principal Investigator: Albert J Yoo, MD, PhD, Texas Stroke Institute; Principal Investigator: Osama O Zaidat, MD, MS, Mercy Health St. Vincent Medical Center

Publications and helpful links

General Publications

• Roaldsen MB, Jusufovic M, Berge E, Lindekleiv H. Endovascular thrombectomy and intra-arterial interventions for acute ischaemic stroke. Cochrane Database Syst Rev. 2021 Jun 14;6(6):CD007574. doi: 10.1002/14651858.CD007574.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): February 25, 2023
• Study Completion (Actual): November 18, 2023

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Thrombectomy; Ischemic Stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2018-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All shared data will be aggregate.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No