Acute Basilar Artery Occlusion: Endovascular Interventions vs Standard Medical Treatment (BEST)

• modified Rankin Scale (mRS) [ Time Frame: at 90 days from randomization ]
  A score of 0-3 will be considered as the favorable outcome.
  
  

• mRS score 0-2 [ Time Frame: at 90 days from randomization ]
  
• Change of mRS score(shift analysis) [ Time Frame: at 90 days from randomization ]
  
• Vessel recanalization rate evaluated by CT angiography or MRA [ Time Frame: at 24 hours from randomization ]
  
• PC-ASPECT score on CT/MRI [ Time Frame: at 24 hours from randomization ]
  
• GCS score [ Time Frame: at 24 hours from randomization ]
  
• NIHSS score [ Time Frame: at 24 hours from randomization ]
  
• GCS score [ Time Frame: at 5-7 days from randomization ]
  
• NIHSS score [ Time Frame: at 5-7 days from randomization ]
  
• EuroQol 5D (EQ-5D) [ Time Frame: at 90 days from randomization ]
  
• mortality [ Time Frame: at 3 months from randomization ]
  
• symptomatic intracerebral hemorrhage (ICH) [ Time Frame: within 24 hours from randomization ]
  
• incidence of non-intracerebral hemorrhage complications [ Time Frame: at 90 days from randomization ]
  
• severity of non-intracerebral hemorrhage complications [ Time Frame: within 90 days from randomization ]
  
• incidence of nonbleeding severe adverse events (SAEs) [ Time Frame: within 90 days from randomization ]
  
• severity of nonbleeding severe adverse events (SAEs) [ Time Frame: within 90 days from randomization ]
  
• incidence of procedure and device related complications [ Time Frame: within 90 days from randomization ]
  i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
  
  
• severity of procedure and device related complications [ Time Frame: within 90 days from randomization ]
  i.e., vessel perforation, clinically significant groin complications, dissection, arterial occlusion and embolization, etc.
  
  

This clinical trial is designed to compare the safety and efficacy of endovascular treatment plus standard medical therapy with standard medical therapy alone for acute BA occlusion presented within 8 h of estimated occlusion time. There is only one ongoing clinical trial-Basilar Artery International Cooperation Study (BASICS) (NCT01717755) aimed to evaluate the efficacy and safety of additional intra-arterial treatment after intravenous treatment in 750 patients with BA occlusion, which was anticipated to be completed in Oct 2017. Initiation of intra-arterial therapy should be feasible within 6 hours of estimated time of BA occlusion. And patients are required to have an NIHSS ≥ 10 at time of randomization, and take IV rt-PA, age between 18-85 years old.

In this trial, the investigators did not have age or NIHSS score limit, patients who did not fulfill the requirements for IV rt-PA can also be included into the trial, the investigators also extended the time window to 8 hours which will accelerate the recruitment of potential subjects. In endovascular treatment arm, the time interval between randomization to procedure finish will be controlled within 120 mins. The preparation of endovascular treatment will start immediately after randomization for those eligible patients for IV rt-PA within 4.5 hours after acute stroke onset, with no need to wait for the one-hour rt-PA infusion. A positive trial will suggest substantial clinical benefit from endovascular treatment plus standard medical therapy over standard medical therapy. This trial may provide novel evidence of adopting endovascular treatment for acute patients with BA occlusion, which may consequently advance our current approach for acute stroke treatment.