BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke

Who can take part

• Patient is ≥ 18 and ≤ 85 years of age
• Informed consent by the patient or legal authorized representative for data collection is obtained
• Patient eligible for the mechanical thrombectomy treatment with adjunctive use of the BOBBY™ BGC
• Patient presenting with an anterior circulation large-vessel occlusion of distal internal carotic artery (ICA ) through proximal M2 confirmed by computed tomograph angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA)
• Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based on baseline CT or MR imaging
• Treatment initiated (groin puncture) within 8 hours of symptom onset
• Patient with a pre-treatment National Institutes of Health Stroke Scale (NIHSS) score ≥5
• Patient with no personal condition disabling the site to contact him/her at 90 days after procedure

Who cannot take part

• Patient is already participating in an investigational drug or device trial (change routine care of the patient)
• Patient presents other serious medical illness (e.g., cancer) with estimated life expectancy of less than 3 months
• Patient has evidence of intracerebral hemorrhage on initial imaging
• Patient has evidence of cerebral ischemia in the posterior circulation
• Patient presents severe unilateral or bilateral carotid artery stenosis requiring stent treatment during the procedure
• Pregnancy or breastfeeding
• Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation
• Patient has a significant mass effect with midline shift