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

Inclusion Criteria:

• Patient is ≥ 18 and ≤ 85 years of age

• Informed consent by the patient or legal authorized representative for datacollection is obtained

• Patient eligible for the mechanical thrombectomy treatment with adjunctive use ofthe BOBBY™ BGC

• Patient presenting with an anterior circulation large-vessel occlusion of distalinternal carotic artery (ICA ) through proximal M2 confirmed by computed tomographangiography (CTA), magnetic resonance angiography (MRA), or digital subtractionangiography (DSA).

• Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based onbaseline 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 daysafter procedure

Exclusion Criteria:

• Patient has evidence of cerebral ischemia in the posterior circulation

• Patient presents severe unilateral or bilateral carotid artery stenosis requiringstent treatment during the procedure

• Pregnancy or breastfeeding

• Patient presents other serious medical illness (e.g., cancer) with estimated lifeexpectancy of less than 3 months

• Patient has a planned procedure that may cause non-compliance with the protocol orconfound data interpretation

• Patient is already participating in an investigational drug or device trial (changeroutine care of the patient)

• Patient has evidence of intracerebral hemorrhage on initial imaging

• Patient has a significant mass effect with midline shift