Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter

Exclusion Criteria19

• Subject was diagnosed with a stroke in the past year.
• Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• Known hemorrhagic diathesis, coagulation factor deficiency, oral anticoagulant therapy with antivitamin K, with INR \>3.0, or thrombocytopenia - baseline platelet count \< 50,000 platelets/mL.
• Known baseline glucose of \<50 mg/dL or \>400 mg/dL.
• Severe, sustained uncontrolled hypertension refractory to treatment (systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg).
• Serious, advanced, or terminal disease with anticipated life expectancy of less than 1 year.
• Known cancer with metastases.
• History of life-threatening allergy (more than rash) to contrast medium.
• Known renal insufficiency with creatinine ≥3 mg/dL or glomerular filtration rate (GFR) \<30 mL/min.
• Subject is a current user or has a recent history of cocaine \&/or heroin use.
• Known pregnancy and/or lactating female.
• Subject is participating in a concurrent study involving an investigational drug or device that would impact the primary endpoint of this study.
• Subject is unlikely to be available for a 90-day follow-up (e.g. no fixed home address, visitor from overseas, etc.)
• CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).
• Significant mass effect with midline shift.
• Evidence of intracranial tumor (except asymptomatic meningioma of ≤ 2cm in diameter).
• Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis.
• History of preexisting stent proximal to or at the occlusion site that may preclude safe deployment or recovery of the stent retriever.
• Vessel tortuosity too difficult to allow endovascular access of the intracranial ICA per investigator judgement. Indicators of vessel tortuosity include but are not limited to the presence of carotid loops and type 3 aortic arches.