The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
NCT ID: NCT03805308
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2019-07-16
2023-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Study Groups
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Medical Management
Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
No interventions assigned to this group
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.
Intra-arterial Therapy
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
Interventions
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Intra-arterial Therapy
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
85 Years
ALL
No
Sponsors
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Mercy Health Ohio
OTHER
Responsible Party
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Dr. Osama O. Zaidat
Neuroscience and Stroke Medical Director
Principal Investigators
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Albert J Yoo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Texas Stroke Institute
Osama O Zaidat, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Mercy Health St. Vincent Medical Center
Locations
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Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
Los Angeles, California, United States
Pomona Valley Hospital Medical Center
Pomona, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
California Pacific Medical Center & Mills Peninsula Medical Center
San Francisco, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Providence Saint John's Health Center
Torrance, California, United States
Boca Raton Regional Hospital Inc.
Boca Raton, Florida, United States
University of Miami
Coral Gables, Florida, United States
Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)
Delray Beach, Florida, United States
Orlando Health Inc.
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Wellstar Health System, Inc.
Marietta, Georgia, United States
The University of Chicago
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center
Lisle, Illinois, United States
Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, United States
Lutheran Medical Group
Fort Wayne, Indiana, United States
Munster Medical Research Foundation
Munster, Indiana, United States
The University of Iowa
Iowa City, Iowa, United States
Baptist Healthcare System Inc. d/b/a Baptist Health Lexington
Lexington, Kentucky, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
University of Massachusetts
Worcester, Massachusetts, United States
McLaren Health Care Corporation
Grand Blanc, Michigan, United States
Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
SSM Health DePaul Hospital
Bridgeton, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
The Community Hospital Group Inc. t/a JFK Medical Center
Edison, New Jersey, United States
Rutgers The State University
Piscataway, New Jersey, United States
University of Buffalo
Buffalo, New York, United States
Feinstein Institute for Medical Research, Northwell
Manhasset, New York, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Mercy Health St. Vincent Medical Center
Toledo, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Tech University of Health Sciences
El Paso, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Texas Stroke Institute
Plano, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Valley Medical Center
Renton, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Aurora Research Institute
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
Other Identifiers
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2018-49
Identifier Type: -
Identifier Source: org_study_id
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