NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 3, 2021

Primary Completion Date

June 6, 2023

Study Completion Date

June 6, 2023

Conditions
Aortic Valve StenosisIntracranial Embolism and Thrombosis
Interventions
PROCEDURE

TAVI (Transcatheter Aortic Valve Implant)

Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures

DEVICE

FLOWer Embolic Protection System

FLOWer Embolic Protection System

Trial Locations (8)

1070

CUB Hôpital Erasme (ULB), Brussels

2020

HartCentrum, Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim, Antwerp

20097

IRCCS Policlinico San Donato, San Donato Milanese

20132

IRCCS Ospedale San Raffaele, Milan

20138

Centro Cardiologico Monzino IRCCS, Milan

20900

Casa di Cura Policlinico di Monza, Monza

28100

Clinica San Gaudenzio, Novara

85100

San Carlo Azienda Ospedaliera Regionale, Potenza

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Meditrial Europe Ltd.

INDUSTRY

lead

AorticLab Srl

INDUSTRY

NCT04704258 - NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device | Biotech Hunter | Biotech Hunter