The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke (TESLA)
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|ClinicalTrials.gov Identifier: NCT03805308|
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Procedure: Intra-arterial Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Outcomes Assessor)|
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.
|Official Title:||The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke|
|Actual Study Start Date :||July 16, 2019|
|Estimated Primary Completion Date :||July 16, 2022|
|Estimated Study Completion Date :||November 1, 2022|
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 Name: Thrombectomy
- 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.
- = 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805308
|Contact: Mary S Patterson, MSfirstname.lastname@example.org|
|Principal Investigator:||Albert J Yoo, MD, PhD||Texas Stroke Institute|
|Principal Investigator:||Osama O Zaidat, MD, MS||Mercy Health St. Vincent Medical Center|