The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
TESLA
1 other identifier
interventional
300
1 country
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2018
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedStudy Start
First participant enrolled
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2023
CompletedApril 23, 2024
April 1, 2024
3.6 years
December 3, 2018
April 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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. 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
Study Arms (2)
Medical Management
NO INTERVENTIONPatients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
Intra-arterial Therapy
EXPERIMENTALFor 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.
Interventions
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
Eligibility Criteria
You may qualify if:
- to 85 years of age
- Presenting with symptoms consistent with an acute ischemic stroke
- Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment
- NIHSS score \>6 at the time of randomization
- Ability to randomize within 24 hours of stroke onset
- Pre-stroke mRS score 0-1
- Ability to obtain signed informed consent
- Imaging evidence of moderate-large infarct defined as:
- \. NCCT ASPECTS 2-5
You may not qualify if:
- 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
- Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
- CT evidence of the following conditions:
- Midline shift or herniation
- Evidence of intracranial hemorrhage
- Mass effect with effacement of the ventricles
- Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
- Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
- Rapidly improving neurological status prior to randomization to NIHSS \<6
- Bilateral strokes or multiple intracranial occlusions
- Intracranial tumors
- 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
- Baseline platelet count \<30,000 per microliter (µl)
- Life expectancy less than 90 days prior to stroke onset
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205, United States
PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
Los Angeles, California, 90017, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
California Pacific Medical Center & Mills Peninsula Medical Center
San Francisco, California, 94107, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360, United States
Providence Saint John's Health Center
Torrance, California, 90503, United States
Boca Raton Regional Hospital Inc.
Boca Raton, Florida, 33486, United States
University of Miami
Coral Gables, Florida, 33146, United States
Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
Delray Beach, Florida, 33484, United States
Orlando Health Inc.
Orlando, Florida, 32806, United States
University of South Florida
Tampa, Florida, 33612, United States
Wellstar Health System, Inc.
Marietta, Georgia, 30062, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Northwestern University
Evanston, Illinois, 60208, United States
AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center
Lisle, Illinois, 60532, United States
Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190, United States
Lutheran Medical Group
Fort Wayne, Indiana, 46804, United States
Munster Medical Research Foundation
Munster, Indiana, 46321, United States
The University of Iowa
Iowa City, Iowa, 52242, United States
Baptist Healthcare System Inc. d/b/a Baptist Health Lexington
Lexington, Kentucky, 40503, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
McLaren Health Care Corporation
Grand Blanc, Michigan, 48439, United States
Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital
Kalamazoo, Michigan, 49008, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
SSM Health DePaul Hospital
Bridgeton, Missouri, 63044, United States
Saint Louis University
St Louis, Missouri, 63103, United States
The Community Hospital Group Inc. t/a JFK Medical Center
Edison, New Jersey, 08820, United States
Rutgers The State University
Piscataway, New Jersey, 08854, United States
University of Buffalo
Buffalo, New York, 14203, United States
Feinstein Institute for Medical Research, Northwell
Manhasset, New York, 11030, United States
ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Tech University of Health Sciences
El Paso, Texas, 79424, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Texas Stroke Institute
Plano, Texas, 75075, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Valley Medical Center
Renton, Washington, 98055, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Aurora Research Institute
Milwaukee, Wisconsin, 53233, United States
Related Publications (2)
Writing Committee for the TESLA Investigators; Yoo AJ, Zaidat OO, Sheth SA, Rai AT, Ortega-Gutierrez S, Given CA 2nd, Zaidi SF, Grandhi R, Cuellar H, Mokin M, Katz JM, Alshekhlee A, Taqi MA, Ansari SA, Siddiqui AH, Barazangi N, English JD, Maud A, Kirmani J, Gupta R, Yavagal DR, Tarpley J, Pandya DJ, Cress MC, Dharmadhikari S, Asif KS, Kass-Hout T, Puri AS, Janjua N, Majjhoo AQ, Badruddin A, Edgell RC, Khatri R, Morgan L, Razak A, Zha A, Khandelwal P, Mueller-Kronast N, Rivet DJ, Wolfe T, Snelling B, Sultan-Qurraie A, Lin SP, Khangura R, Spiotta AM, Bhuva P, Salazar-Marioni S, Lin E, Tarabishy AR, Samaniego EA, Kolikonda MK, Jumaa MA, Reddy VK, Sharma P, Berkhemer OA, van Doormaal PJ, van Es ACGM, van Zwam WH, Emmer BJ, Beenen LF, Majoie CBLM, Buderer N, Detry MA, Bosse A, Graves TL, Saunders C, Elijovich L, Jadhav A, Patterson M, Slight H, Below K, Al Kasab S; TESLA Investigators. Thrombectomy for Stroke With Large Infarct on Noncontrast CT: The TESLA Randomized Clinical Trial. JAMA. 2024 Sep 23;332(16):1355-66. doi: 10.1001/jama.2024.13933. Online ahead of print.
PMID: 39374319DERIVEDRoaldsen 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.
PMID: 34125952DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert J Yoo, MD, PhD
Texas Stroke Institute
- PRINCIPAL INVESTIGATOR
Osama O Zaidat, MD, MS
Mercy Health St. Vincent Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The patient and the treating physician will be aware of the treatment assignment. Assessment of outcome on NIHSS and mRS will be performed by a certified rater blinded to the treatment allocation. Each site must designate one or more individual(s) to perform these blinded assessments at 24 (16-36) hours, 6 ± 1 days or discharge (whichever is earlier), 30 days ± 7 days, and 90 days ± 30 days from randomization. Neuroimaging core lab evaluation will also be assessed in a blinded manner, except for angiographic revascularization grading which will only be performed for the intra-arterial treatment arm. Information on treatment allocation will be stored separately from the main study database. An unblinded independent statistician will combine treatment allocation data with the clinical data in order to report to the DSMB. A second blinded statistician will be part of the steering committee.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neuroscience and Stroke Medical Director
Study Record Dates
First Submitted
December 3, 2018
First Posted
January 15, 2019
Study Start
July 16, 2019
Primary Completion
February 25, 2023
Study Completion
November 18, 2023
Last Updated
April 23, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
All shared data will be aggregate.