NCT05409430

ANAIS Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access®

Prospective, Single-arm, Multi-center Study to Confirm the Safety and Performance of the ANA 5F Advanced Neurovascular Access®, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke (ANAIS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Anaconda Biomed S.L. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single-arm, multi-center study to assess the safety and performance of the ANA 5F Advanced Neurovascular Access®, in combination with a stent retriever in patients with acute ischemic stroke.

Detailed description

ANA 5F Advanced Neurovascular Access®: distal access catheter system designed to assist in neurovascular procedures by facilitating the insertion and guidance of other devices (i.e. retrieval devices and intravascular catheters) and temporarily restricting blood flow at the target position. The objective of this study is to confirm the safety and performance of the ANA 5F device to be used as a tool to facilitate the Solitaire stent retriever placement and provide temporary restriction of blood flow in stroke patients undergoing neurothrombectomy for an acute large vessel occlusion (LVO) treated 24 hours from symptom onset (last time the subject was seen well). Population: Up to 30 Participants with Acute Ischemic Stroke (AIS), indicated for treatment with ANA 5F device in combination with Solitaire stent retriever, whose stroke is attributable to an occlusion of a large artery in the neurovasculature.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Neurothrombectomy	The ANA 5F device is intended to be inserted, be navigated to the neurovascular anatomy inside an outer catheter and be used as a conduit for insertion and guidance of intravascular catheters and retrieval devices into a selected blood vessel. The funnel is deployed by retracting the conduit catheter and is intended, when deployed, to provide temporary vascular flow restriction. The device is indicated for the introduction of interventional devices into the neuro vasculature, during interventions for restoring blood flow in patients experiencing acute ischemic stroke due to large vessel occlusion.

Timeline

• Start date: 2022-05-09
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2022-06-08
• Last updated: 2023-07-20

Locations

3 sites across 1 country: Spain