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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Procedure: Intra-arterial Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Ability to obtain signed informed consent Imaging evidence of moderate-large infarct defined as: 1. NCCT ASPECTS 2-5 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Medical Management<br>Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines. | |
| Experimental: Intra-arterial Therapy<br>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<br>* Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.<br>* Other names: Thrombectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. = 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 | 90 days post randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Ischemic Stroke, Thrombectomy