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Ischemic StrokeTESLANCT03805308

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

A study testing Intra-arterial Therapy in people with Ischemic Stroke, run by Mercy Health Ohio at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Ischemic Stroke
What is being tested?
Intra-arterial Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
43 sitesUnited States
Study dates
16 Jul 2019to 18 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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
Show all 9Show fewer
  • Ability to obtain signed informed consent
  • Imaging evidence of moderate-large infarct defined as:
  • 1. NCCT ASPECTS 2-5

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Participation in another randomized clinical trial that could confound the evaluation of the study
  • 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

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Boca Raton Regional Hospital Inc.

    Boca Raton, Florida, 33486

  • SSM Health DePaul Hospital

    Bridgeton, Missouri, 63044

  • University of Buffalo

    Buffalo, New York, 14203

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The University of Chicago

    Chicago, Illinois, 60637

  • University of Miami

    Coral Gables, Florida, 33146

  • Tenet Health Systems (Delray Medical Center, St. Mary's Medical Center, Palmetto General Hospital)

    Delray Beach, Florida, 33484

  • The Community Hospital Group Inc. t/a JFK Medical Center

    Edison, New Jersey, 08820

  • Texas Tech University of Health Sciences

    El Paso, Texas, 79424

  • Northwestern University

    Evanston, Illinois, 60208

  • Lutheran Medical Group

    Fort Wayne, Indiana, 46804

  • McLaren Health Care Corporation

    Grand Blanc, Michigan, 48439

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • The University of Iowa

    Iowa City, Iowa, 52242

  • Western Michigan University Homer Stryker MD School of Medicine and Bronson Methodist Hospital

    Kalamazoo, Michigan, 49008

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Baptist Healthcare System Inc. d/b/a Baptist Health Lexington

    Lexington, Kentucky, 40503

  • AMITA Resurrection Medical Center and AMITA Saint Joseph Medical Center

    Lisle, Illinois, 60532

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas, 72205

  • PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital

    Los Angeles, California, 90017

  • Feinstein Institute for Medical Research, Northwell

    Manhasset, New York, 11030

  • Wellstar Health System, Inc.

    Marietta, Georgia, 30062

  • Aurora Research Institute

    Milwaukee, Wisconsin, 53233

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Munster Medical Research Foundation

    Munster, Indiana, 46321

  • Orlando Health Inc.

    Orlando, Florida, 32806

  • Rutgers The State University

    Piscataway, New Jersey, 08854

  • Texas Stroke Institute

    Plano, Texas, 75075

  • Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • Valley Medical Center

    Renton, Washington, 98055

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • Sutter Institute for Medical Research

    Sacramento, California, 95816

  • University of Utah

    Salt Lake City, Utah, 84112

  • California Pacific Medical Center & Mills Peninsula Medical Center

    San Francisco, California, 94107

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • Saint Louis University

    St Louis, Missouri, 63103

  • University of South Florida

    Tampa, Florida, 33612

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 91360

  • ProMedica Toledo Hospital

    Toledo, Ohio, 43606

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio, 43608

  • Providence Saint John's Health Center

    Torrance, California, 90503

  • Central DuPage Hospital Association d/b/a Northwestern Medicine Central DuPage Hospital

    Winfield, Illinois, 60190

  • University of Massachusetts

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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.

Read the 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.

Conditions
Ischemic Stroke
Being tested
Intra-arterial Therapy
Keywords
Stroke, Ischemic Stroke, Thrombectomy
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intra-arterial TherapyProcedure or surgery

    Also called Thrombectomy

    Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.

Study groups in NCT03805308
Study groupRoleWhat they receive
Medical ManagementNo interventionPatients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
Intra-arterial TherapyExperimentalFor 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.
Receives: Procedure: Intra-arterial Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 90 days post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start16 Jul 2019
  3. Primary completion25 Feb 2023
  4. Study completion18 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
TESLA is a pragmatic, phase III, prospective, randomized, open-label, blinded endpoint, multicenter trial. Patients with moderate-large infarcts will be assigned to either best medical management alone (including intravenous recombinant tissue-type plasminogen activator (IV rtPA)) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the instructions for use (IFU). Patients will be enrolled at up to 25 centers over an anticipated three-year period, with an additional year for trial closeout.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03805308
Sponsor's protocol ID
2018-49
Acronym
TESLA
Status last verified
Apr 2024
First submitted
3 Dec 2018
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All shared data will be aggregate.

Publications

  • 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.

    PubMed 39374319

  • 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.

    PubMed 34125952

Questions about this trial

What is this clinical trial studying?

A study testing Intra-arterial Therapy in people with Ischemic Stroke, run by Mercy Health Ohio at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Utility-weighted 90-day Modified Rankin Score (time frame: 90 days post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03805308, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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