Study of Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke; Infarction
Study type: Interventional

Summary: 
      Endovascular therapy (EVT) was recommended as the primary treatment for patients with acute
      large vascular occlusion (LVO) in anterior circulation. However, the evidences of EVT for
      patients with large infarct volume were limited. In this study, the investigators assume that
      best medical management plus EVT might be superior than best medical management alone for
      patients who have evidence of a large infarct volume. The primary objective of the study was
      to establish the safety and efficacy of EVT in patients presenting with symptoms of acute
      ischemic stroke (AIS) from LVO in the anterior circulation and having a large infarct volume.
    

Detailed description: 
      The ANGEL-ASPECT is a multicentered, prospective, randomized, open-label, blinded end-point
      (PROBE) study. A total of approximately 488 patients (age from 18 to 80 years) within 24
      hours of symptom onset of acute ischemic stroke, who has the imaging evidence of an occlusion
      of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA
      M1) segment, large infarct core [ defined as: 1) NCCT (noncontrast computed tomography)
      ASPECTS (Alberta Stroke Program Early CT Score) 3-5, decided on last head CT scan before
      randomization. 2) Ischemic core volume ranges from 70-100ml, determined either on a
      diffusion-weighted MRI map based on an ADC (Apparent Diffusion Coefficient) threshold of less
      than 620 ×10-6mm2/s or on CTP (computed tomography perfusion) image with rCBF<30%] will be
      enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion
      criteria will be randomized 1:1 into two groups after offering informed content. One group
      will receive best medical management alone the other group will receive best medical
      management plus EVT including mechanical thrombectomy, aspiration thrombectomy,
      intra-arterial thrombolysis, angioplasty or stenting. The primary objective is to establish
      the efficacy of EVT in patients presenting with symptoms of acute ischemic stroke (AIS) from
      LVO in the anterior circulation and having a large infarct volume. The study consists of six
      visits including the day of randomization, 2 days after randomization, 7 days or discharge,
      and 30, 90 days and 1 year. Demographic information, symptoms and signs, laboratory test,
      neuro-imaging assessment neurological function rating scale will be recorded during the
      program. The primary endpoint is the modified Rankin's scale (mRS) at 90 days. The trial is
      anticipated to last from September 2020 to October 2022 with 488 subjects recruited form
      about 50 centers in China. All the related investigative organization and individuals will
      obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and
      Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has
      been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Being Tiantan
      hospital, Capital Medical University.
    

Intervention name(s): Best medical management; Endovascular therapy
Intervention type(s): Drug; Procedure
Intervention description(s): All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.; In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy (recommended with Solitaire、EMBOTRAP、Trevo or Reco revascularization device) or aspiration thrombectomy (recommended with Penumbra) will be recommended as the primary treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: endovascular therapy; large infarct volume