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

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.

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:

• 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