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

April 22, 2024 updated by: Dr. Osama O. Zaidat, Mercy Health Ohio
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Utility-weighted 90-day Modified Rankin Score
Time Frame: 90 days post randomization

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.

  1. = No significant disability despite symptoms; able to carry out all usual duties and activities.
  2. = Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance.
  3. = Moderate disability requiring some help, but able to walk without assistance.
  4. = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.
  5. = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention.
  6. = Death
90 days post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mercy Health Ohio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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