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ACTIVE NOT RECRUITING
NCT05721001

French Registry Conducted on E-vita OPEN NEO

Sponsor: JOTEC GmbH

View on ClinicalTrials.gov

Summary

Observational, prospective/retrospective, non-randomised, non-comparative, multicentre cohort study. Primary objective is evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO.

Official title: NEO - E-vita Open Neo Treatment of Aortic Arch Aneurysms and Dissections

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2023-01-11

Completion Date

2027-08-31

Last Updated

2025-03-28

Healthy Volunteers

No

Interventions

DEVICE

Surgical Repair

In Frozen Elephant Trunk procedure, the proximal aortic arch is replaced with a dacron graft, and a thoracic stent graft, sutured to the distal end of the dacron prosthesis, is deployed antegradely into the descending aorta. This mostly one-stage alternative approach eliminates the interval mortality rate related to the conventional elephant trunk procedure. Moreover, it constitutes a solution in fragile patients who cannot safely complete a second major operation after surviving the first.

Locations (23)

CHU Amiens-Picardie

Amiens, France

Centre Hospitalo-Universitaire d'Angers

Angers, France

Centre Hospitalier Annecy Genevois

Annecy, France

CHU Besançon

Besançon, France

Clinique Saint-Augustin

Bordeaux, France

Hôpital de La Cavale Blanche - Brest

Brest, France

Hôpital Louis PRADEL

Bron, France

Hôpital Privé Saint-Martin

Caen, France

Clinique de l'Infirmerie Protestante

Caluire-et-Cuire, France

Hôpital Gabriel Montpied

Clermont-Ferrand, France

Chu Henri Mondor

Créteil, France

CHU le Bocage - CHU de Dijon

Dijon, France

Hôpital Privé Bois Bernard

Lens, France

CHU Lille

Lille, France

CHRU Limoges - Dupuytren

Limoges, France

CHU Montpellier

Montpellier, France

Groupe Hospitalier de la région de Mulhouse et Sud Alsace GHRMSA (Mulhouse)

Mulhouse, France

APHP Pitié Salpétrière

Paris, France

CHU de Poitiers

Poitiers, France

CHU de Rennes - CHRU Pontchaillou

Rennes, France

CHU Rouen (Charles Nicolle)

Rouen, France

Hopitaux Universtaires Strasbourg

Strasbourg, France

CHU de Tours - Hôpital Trousseau

Tours, France