NCT05721001

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

23 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2023Aug 2027

First Submitted

Initial submission to the registry

January 6, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 11, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Expected
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

January 6, 2023

Last Update Submit

March 25, 2025

Conditions

Vascular Aneurysm

Keywords

ThoracicAortaAneurysmDissectionOpenRepairFrozenElephantTrunk

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Rate of in-hospital all-cause mortality

    through study completion, an average of 3 years

Secondary Outcomes (21)

  • Mortality

    1 year and 3 years

  • Morbidity

    1 year and 3 year

  • Severe Adverse Events

    1 year

  • Severe Adverse Events

    3 years

  • Neurological complications

    At discharge, an average of 45 days, 1 year, 3 years

  • +16 more secondary outcomes

Interventions

Surgical RepairDEVICE

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.

Also known as: Frozen Elephant Trunk Technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All male and female patients who have undergone implantation of E-vita OPEN NEO at their physician's discretion in France since device CE marking in 2020 and until 31st March 2024 will receive a non-objection letter. If patient does not object to his/her data collection, patient will be enrolled and data collection can start.

You may qualify if:

  • non-objection from the patient for data collection within this Registry
  • patient treated with E-vita Open NEO

You may not qualify if:

  • objection from the patient for data collection within this Registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

CHU Amiens-Picardie

Amiens, 80054, France

Location

Centre Hospitalo-Universitaire d'Angers

Angers, 49933, France

Location

Centre Hospitalier Annecy Genevois

Annecy, 74374, France

Location

CHU Besançon

Besançon, 25030, France

Location

Clinique Saint-Augustin

Bordeaux, 33074, France

Location

Hôpital de La Cavale Blanche - Brest

Brest, 29 200, France

Location

Hôpital Louis PRADEL

Bron, 69677, France

Location

Hôpital Privé Saint-Martin

Caen, 14000, France

Location

Clinique de l'Infirmerie Protestante

Caluire-et-Cuire, 69300, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Chu Henri Mondor

Créteil, 94010, France

Location

CHU le Bocage - CHU de Dijon

Dijon, 21079, France

Location

Hôpital Privé Bois Bernard

Lens, 62320, France

Location

CHU Lille

Lille, 59000, France

Location

CHRU Limoges - Dupuytren

Limoges, 87042, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

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

Mulhouse, 68100, France

Location

APHP Pitié Salpétrière

Paris, 75013, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CHU de Rennes - CHRU Pontchaillou

Rennes, 35033, France

Location

CHU Rouen (Charles Nicolle)

Rouen, 76000, France

Location

Hopitaux Universtaires Strasbourg

Strasbourg, 67091, France

Location

CHU de Tours - Hôpital Trousseau

Tours, 37 170, France

Location

MeSH Terms

Conditions

Aneurysm

Interventions

Sutureless Surgical Procedures

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Wound Closure TechniquesSurgical Procedures, Operative

Study Officials

  • Olivier Fouquet, Prof

    Centre Hospitalo-Universitaire d'Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2023

First Posted

February 9, 2023

Study Start

January 11, 2023

Primary Completion

March 15, 2024

Study Completion (Estimated)

August 31, 2027

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

FR(23)