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TESLA Trial: Rationale, Protocol, and Design.

Osama O Zaidat1, Sami Al Kasab2, Sunil Sheth3

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Summary
This summary is machine-generated.

Mechanical thrombectomy shows promise for large ischemic strokes. The TESLA trial investigates its efficacy and safety compared to medical management in patients with large infarcts diagnosed via noncontrast CT scans.

Keywords:
TESLA trialclinical trialdesignlarge‐core infarctlarge‐vessel occlusionstrokethrombectomy

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Area of Science:

  • Neurology
  • Interventional Radiology
  • Clinical Trials

Background:

  • Mechanical thrombectomy is effective for acute ischemic stroke with small to moderate infarcts.
  • Randomized trials are lacking for large-core infarcts diagnosed solely by noncontrast CT.
  • The TESLA trial addresses this gap in treatment guidelines.

Purpose of the Study:

  • To demonstrate the efficacy and safety of mechanical thrombectomy in large-volume ischemic stroke.
  • To compare outcomes of thrombectomy versus best medical management in selected patients.
  • To evaluate disability and mortality at 90 days and 1 year.

Main Methods:

  • Prospective, randomized, controlled, multicenter, open-label, assessor-blinded trial.
  • Enrollment of up to 300 patients with anterior circulation large-vessel occlusion and large infarcts on noncontrast CT (ASPECTS 2-5).
  • Randomization (1:1) to mechanical thrombectomy or best medical management within 24 hours of last known well.

Main Results:

  • Primary efficacy outcome: utility-weighted modified Rankin Scale (mRS) distribution at 90 days.
  • Primary safety outcome: 90-day mortality rate.
  • Secondary outcomes include dichotomized mRS, ordinal mRS, quality of life, and symptomatic intracranial hemorrhage rates.

Conclusions:

  • The TESLA trial is a pragmatic study evaluating thrombectomy for large infarcts diagnosed by noncontrast CT.
  • It aims to provide crucial evidence for treating acute ischemic stroke patients with large-core infarcts.
  • Results will inform clinical practice regarding thrombectomy in this specific patient population.