Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter
Trial Parameters
Brief Summary
The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy (MT) using the ANA funnel catheter in its intended use, which is to facilitate the navigation and deployment of other neurovascular devices and to allow flow arrest during mechanical thrombectomy procedures performed in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset.
Eligibility Criteria
Key Inclusion Criteria: Subjects meeting all inclusion criteria will be considered for enrollment in the study. 1. Age 22 to 85 years. 2. Informed consent was obtained from subject or acceptable subject surrogate (e.g., next of kin, or legal representative). 3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia. 4. Baseline NIHSS obtained prior to procedure ≥ 6 points and ≤ 25 points. 5. Pre-ictal mRS score of 0,1 or 2. 6. Treatable within 16 hours of symptom onset, defined as point in time when the subject was last observed to be asymptomatic; treatment start is defined by arterial puncture time. 7. If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay. 8. Occlusion (eTICI ≤ 1 flow) of the terminal carotid artery, middle cerebral artery M1 segment or, dominant or proximal M2 segment, indicated for me