Endovascular Stroke Treatment Only (ESTO) Trial
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      The specific aims of this study are to:

        1. Determine whether the endovascular treatment (mechanical thrombectomy) alone without
           using intravenous (IV) recombinant tissue plasminogen activator (rt-PA) in acute
           ischemic stroke patients demonstrates "promise" or a lack thereof ("futility") in
           deciding what would be the next phase III trial.

        2. Determine the proportion of subjects with slight or no disability (a modified Rankin
           score (mRS) of 0-2) at 3 months after receiving endovascular treatment (mechanical
           thrombectomy) alone without using IV rt-PA and compare with historical controls who were
           treated with IV rt-PA to identify (or lack of) futility.

        3. Determine the proportion of subjects with improvement in the National Institutes of
           Health Stroke Scale (NIHSS) score of ≥8 points or achieving a score of 0-1 at 24 hours
           after the onset of stroke among subjects with acute ischemic stroke after receiving
           endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.

        4. Determine the proportion of subjects with angiographic recanalization on post procedure
           angiogram according to modified Thrombolysis in Cerebral Infarction (TICI) perfusion
           flow categories among subjects with acute ischemic stroke after receiving endovascular
           treatment (mechanical thrombectomy) alone without using IV rt-PA.

        5. Determine the proportion of subjects with treatment-related serious adverse events
           (SAEs) within 72 hours and development of symptomatic intracranial hemorrhage at 27
           ±3hrs post treatment among subjects with acute ischemic stroke after receiving
           endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.
    

Detailed description: 
      A phase II trial is proposed to address the question whether administration of intravenous
      (IV) recombinant tissue plasminogen activator (rt-PA) in acute ischemic stroke patients who
      are candidates for endovascular treatment provides any additional value. The phase II trial
      will treat consecutive patients who are candidates for IV rt-PA and mechanical thrombectomy
      with just mechanical thrombectomy alone. Such trial will generate the necessary data for a
      definitive phase III trial. The trial is designed based on low rate of recanalization in
      patients with major arterial occlusion with IV rt-PA alone and no difference in rate of
      recanalization or distal embolization in patients who receive IV rt-PA and those who do not
      prior to mechanical thrombectomy. The rates of intracranial hemorrhage (ICH) and cost of
      hospitalization are higher when IV rt-PA is administered prior to mechanical thrombectomy.
      The trial will determine the proportion of patients with slight or no disability (a modified
      Rankin score (mRS) of 0-2) at 3 months after receiving endovascular treatment (mechanical
      thrombectomy) alone without using IV rt-PA and compare with historical controls who were
      treated with IV rt-PA to determine futility.
    

Intervention name(s): Thrombectomy
Intervention type(s): Procedure
Intervention description(s): Participants will receive endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.
Intervention model: Single Group Assignment
Intervention model description: Participants will be assigned to receive endovascular treatment for acute ischemic stroke (mechanical thrombectomy) alone without using IV rt-PA.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute ischemic stroke; endovascular treatment; recombinant tissue plasminogen activator; mechanical thrombectomy