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.
Similar to other ancillary devices used in MT, the ANA device is designed to facilitate the delivery of stent retrievers and other catheters during these procedures. Its design aims to enhance procedural success and the efficiency of stent retriever-based MT by enabling flow arrest during clot retrieval. This approach has been shown to improve rates of revascularization and favorable clinical outcomes at three months. The use of the ANA to facilitate MT with a stent retriever may provide a simplified approach to flow restriction and could achieve acute reperfusion outcomes comparable to commonly used strategies that combine direct aspiration with an intermediate catheter to actuate clot retrieval with a SR. A dual-arm, prospective, randomized study will be conducted to demonstrate the safety and effectiveness of ANA compared to a conventional approach using cleared stent retrievers for MT. The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly employed stent retrievers: Solitaire, Trevo, and pRESET. Procedural safety will be assessed by comparing the rate of procedure-related sICH within 24 hours of the intervention between study arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
327
Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.
Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.
Baptist Health Medical Center
Jacksonville, Florida, United States
Proportion of subjects with "near-complete" reperfusion after one thrombectomy pass (FPE, eTICI 2c-3, extended Thrombolysis in Cerebral Infarction scale) in the target vessel.
Reperfusion (eTICI 2c-3) to be assessed by an independent Core Lab.
Time frame: intra-operative
Rate of symptomatic intracranial hemorrhage (sICH), attributable to the device or procedure.
Extent of hemorrhage to be assessed by an independent Core Lab, symptoms to be assessed by the Data Monitoring Committee (DMC).
Time frame: Within 24 hours of the procedure
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