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

Prior treatment

• Rapidly improving neurological status prior to randomization to NIHSS \<6
• Life expectancy less than 90 days prior to stroke onset

Other illness

• 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
• Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
• 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

Lab values

• Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
• 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)

Other

• Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
• Bilateral strokes or multiple intracranial occlusions
• Intracranial tumors
• Participation in another randomized clinical trial that could confound the evaluation of the study

• 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