NCT04095767

Assessing Safety and Performance of the ANA Catheter System, Combined With a Stent Retriever in Acute Ischemic Stroke

Prospective, Single-Arm, Multi-center Study to Assess the Safety and Performance of the ANA Catheter System, in Combination With a Stent Retriever in Patients With Acute Ischemic Stroke

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Anaconda Biomed S.L. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The ANA catheter system (may also be designated as "ANA system", "ANA 18 -002" or "ANA device") is a distal access catheter designed to assist in neurovascular procedures by facilitating the insertion and guiding of other devices (i.e. retrieval devices and intravascular catheters) and restricting blood flow at the target position. It is a sterile, single-use, disposable intravascular device comprised of two coaxial catheters (delivery catheter and funnel catheter) consisting of sections of variable stiffness. The funnel catheter is comprised of a radiopaque nitinol braid (self-expanding funnel), covered by a continuous silicone coating that, when deployed, provides local and temporary flow restriction. The delivery catheter has a hydrophilic coating to reduce friction during use and a radiopaque marker on the distal end. Both catheters have Luer lock hubs on their proximal end. The proposed study has been designed to collect prospective clinical evidence to compare the Anaconda ANA device to similar devices used for guiding and supporting stent retrievers during neurothrombectomy procedures. The protocol has been designed to replicate the patient population enrolled in prior studies of similar devices. The primary endpoint will be ability of the investigational device to facilitate stentriever deployment and neurothrombectomy in the anterior circulation, with successful reperfusion defined as achieving a modified Thrombolysis in Cerebral Infarction (mTICI) score of ≥2b in the target vessel with ≤3 passes of the investigational device without the use of rescue therapy. Follow-up at 24h, Day 5 (+/- 12 h) or discharge, whichever comes first and at 90 days will allow documentation of the clinical outcome of the neurothrombectomy procedure as a whole and detect any device related and other complications, making use of the ANA device for distal access.

Conditions

• Stroke, Ischemic

Interventions

Type	Name	Description
DEVICE	Neurothrombectomy	Intra-arterial recanalization therapy or mechanical thrombectomy (MT) is a therapeutic option for patients who are not candidates for t-PA or in whom t-PA has failed. MT is performed by means of various devices (Merci Revive, Penumbra, etc.). There are currently two major approaches to MT: the so-called stent retrievers (used with or without a balloon catheter), and catheters used for direct aspiration (manual with syringe or by aspiration pump via distal access catheters \[DACs\]). Moreover, both techniques can be combined. MT may be performed following IV t-PA, as a stand alone therapy, or in conjunction with IA thrombolysis.

Timeline

• Start date: 2019-09-21
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2019-09-19
• Last updated: 2021-07-02

Locations

9 sites across 1 country: Spain