Acute Ischemic Stroke From Large Vessel Occlusion Clinical Trial
Official title:
A Prospective, Randomized, Dual-arm Multi-center Study to Assess the Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device in Combination With a Stent Retriever
The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy using the ANA funnel catheter to treat people with acute ischemic stroke within 24 hours of symptom onset. The device facilitates the placement of other devices such as stent retrievers and intravascular catheters during the procedure.
The objective of this prospective randomized study is to assess the primary safety and effectiveness of mechanical thrombectomy (MT) using the ANA funnel catheter in its intended use as a device to facilitate the insertion and deployment of other devices (i.e., stent retrievers and intravascular catheters) and to allow flow restriction during MT procedures performed in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) of the internal carotid artery (ICA) and treated within 24 hours of symptom onset. Acute reperfusion success after one pass (First Pass Effect, FPE) with ANA will be compared to an active control using the same stent retrievers delivered by an approved guide catheter with or without an intermediate catheter per conventional techniques. The study is designed to demonstrate that the use of ANA does not adversely impact the safety and effectiveness of a conventional stent retriever MT procedure. 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 efficiency of stent retriever-based MT procedures by facilitating flow arrest during clot retrieval. This approach has been shown to improve rates of revascularization and good clinical outcome after three months. Numerous studies have established the value of flow arrest during MT, yet it is only used in a minority of procedures most likely due to concerns related to navigability, complexity and safety of the currently available devices. Use of the ANA to facilitate MT with a stent retriever may provide a simplified approach to flow restriction, and may achieve similar acute reperfusion outcomes to commonly used approaches that combine direct aspiration with an intermediate catheter to actuate clot retrieval with a stent retriever (control). The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly employed stent retrievers, namely 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. ;
| Status | Clinical Trial | Phase | |
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| Completed |
NCT01584609 -
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
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N/A |