NCT06370182

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

A Prospective, Randomized, Dual-arm Multi-center Study to Assess the Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA Funnel Catheter in Combination With a Stent Retriever

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 327 (estimated)
• Sponsor: Anaconda Biomed S.L. · Industry
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Ischemic Stroke From Large Vessel Occlusion

Interventions

Type	Name	Description
DEVICE	ANA Funnel Catheter	Mechanical thrombectomy using a stent retriever delivered by the ANA device that enables local flow restriction when deployed.
DEVICE	Control	Mechanical thrombectomy using a stent retriever delivered by an approved guide catheter with or without an intermediate catheter and aspiration per conventional techniques.

Timeline

• Start date: 2024-09-09
• Primary completion: 2027-08-01
• Completion: 2027-12-01
• First posted: 2024-04-17
• Last updated: 2025-12-11

Locations

22 sites across 5 countries: United States, France, Hungary, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated device study