French Registry Conducted on E-vita OPEN NEO (NEO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Aneurysm
• Intervention / Treatment: Device: Surgical Repair

Detailed Description

Objectives

Primary objective:

• Evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO

Secondary objective:

• Evaluation of the morbi-mortality in-hospital, 1 year and 3 years follow-up after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO.

Morbidity is defined as:

• new permanent (> 30 days) neurological complications (stroke mRS > 2, spinal cord ischemia, paraparesis, paraplegia)
• new clinical malperfusion (including visceral malperfusion)
• new permanent (>90 days) renal insufficiency requiring dialysis or hemofiltration in patients with normal pre-procedure serum creatinine level The others secondary objectives are to assess changes of the stent graft system in the medium (1 year) and long term (3 years):
• type Ib, II, or IV endoleaks in patients with aneurysm or type Ib or II entry flow in patients with dissection
• permeability of the vascular part

Patient population All patients treated with E-vita OPEN NEO until 31st March 2024 will be included in this registry if they are not opposed to the study. Follow-up of these patients will end in 2027.

Patients to be documented:

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.

Inclusion/Exclusion Criteria None Indications for Use for E-vita OPEN NEO are listed in the device IFU. Patients are treated with E-vita OPEN NEO at the discretion of the treating physician.

Methodology In this study, we will conduct an observational cohort of consecutive patients who receive / received an E-vita OPEN NEO implant for the treatment of extensive acute or chronic aortic pathologies until 31st March, 2024. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with E-vita OPEN NEO. All patients will be provided with a non-objection letter and given the opportunity to refuse to participate. Patients will either receive the non-objection letter before treatment or it is mailed to them by their treating physician.

A screening log will be kept during the study. In the screening log it will be documented which patients objected to the collection of their data and were therefore not included in the registry. The number of E-vita OPEN NEO implanted in France during the enrolment phase of the study will be submitted and compared to the number of patients enrolled in the study to assess the coverage of the study.

Patient data will be documented at the following time points: Pre-operative planning, intervention, prior to discharge from hospital, 1 year, and 3 years follow-up. The period of data collection will be 3 years ± 6 months (depending on the time point of the 3 years follow-up visit) starting from the intervention for each patient. All adverse events defined prior to study start will be adjudicated by the Clinical Event Committee (CEC).

Inclusion period (retrospective/prospective): Q3 2022 till Q1 2024 Follow-up: 3 years Total study period: 6 years

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Emilie Chilaud; Phone Number: +49 7471 922 0; Email: emilie.chilaud@artivion.com
• Study Contact Backup: Name: Jochen Kobert; Phone Number: +49 7471 922 0; Email: Jochen.Kobert@artivion.com

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens-Picardie
    • Contact: Majid Harmouche, Dr.
  • Angers, France, 49933
    • Recruiting
    • Centre Hospitalo-Universitaire d'Angers
    • Contact: Olivier Fouquet, Prof.
  • Annecy, France, 74374
    • Recruiting
    • Centre Hospitalier Annecy Genevois
    • Contact: Sebastian Gerelli, Dr.
  • Besançon, France, 25030
    • Recruiting
    • CHU Besançon
    • Contact: Andrea Perrotti, Prof.
  • Bordeaux, France, 33074
    • Recruiting
    • Clinique Saint-Augustin
    • Contact: Emmanuel Choukroun, Dr.
  • Brest, France, 29 200
    • Recruiting
    • Hôpital de La Cavale Blanche - Brest
    • Contact: Eric Bezon, Prof.
  • Bron, France, 69677
    • Recruiting
    • Hôpital Louis Pradel
    • Contact: Daniel Grinberg, Dr.
  • Caen, France, 14000
    • Recruiting
    • Hôpital Privé Saint-Martin
    • Contact: Julien Desgué, Dr.
  • Caluire-et-Cuire, France, 69300
    • Recruiting
    • Clinique de l'infirmerie Protestante
    • Contact: Fadi Farhat, Prof.
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • Hôpital Gabriel Montpied
  • Dijon, France, 21079
    • Recruiting
    • CHU le Bocage - CHU de Dijon
    • Contact: Olivier Bouchot, Prof
  • Lens, France, 62320
    • Recruiting
    • Hôpital Privé Bois Bernard
    • Contact: Ilir Hysi, Dr.
  • Lille, France, 59000
    • Recruiting
    • CHU Lille
    • Contact: André Vincentelli, Prof.
  • Limoges, France, 87042
    • Recruiting
    • CHRU Limoges - Dupuytren
    • Contact: Alessandro PICCARDO, Dr.
  • Montpellier, France, 34295
    • Recruiting
    • CHU Montpellier
    • Contact: Thomas Gandet, Prof.
  • Mulhouse, France, 68100
    • Recruiting
    • Groupe Hospitalier de la région de Mulhouse et Sud Alsace GHRMSA (Mulhouse)
    • Contact: Gheorge Gavra, Dr.
  • Paris, France, 75013
    • Recruiting
    • Aphp Pitie Salpetriere
    • Contact: Guillaume Lebreton, Prof.
  • Rouen, France, 76000
    • Recruiting
    • CHU Rouen (Charles Nicolle)
    • Contact: Chadi Aludaat, Dr.
  • Strasbourg, France, 67091
    • Recruiting
    • Hopitaux Universtaires Strasbourg
    • Contact: Arnaud Mommerot, Dr.
  • Tours, France, 37 170
    • Recruiting
    • CHU DE TOURS - Hopital Trousseau
    • Contact: Thierry Bourgignon, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• objection from the patient for data collection within this Registry

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Rate of in-hospital all-cause mortality	through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All-cause mortality	1 year and 3 years
Morbidity	new neurological complication (defined as stroke, spinal cord ischemia, paraparesis, paraplegia), new clinical malperfusion (including visceral malperfusion), new permanent (> 90 days) renal insufficiency requiring dialysis or hemofiltration in patients with normal pre-procedure serum creatinine level	1 year and 3 year
Severe Adverse Events	Rate of patients with SAE until 1 year follow-up (device-related, procedure-related, disease-related)	1 year
Severe Adverse Events	Rate of patients with SAE between 1 year and 3 year year follow-up (device-related, procedure-related, disease-related)	3 years
Neurological complications	Rate of patients with New permanent (> 30 days) neurological complications	At discharge, an average of 45 days, 1 year, 3 years
Neurological complications	Rate of patients with New transient (≤ 30 days) neurological complications	At discharge, an average of 45 days, 1 year, 3 years
Stroke	New permanent (> 30 days) stroke	At discharge, an average of 45 days, 1 year, 3 years
Stroke	Rate of patients with New transient (≤ 30 days) stroke	At discharge, an average of 45 days, 1 year, 3 years
Paraplegia	Rate of patients with New permanent (> 30 days) paraplegia	At discharge, an average of 45 days, 1 year, 3 years
Paraparesis	Rate of patients with New permanent (> 30 days) paraparesis	At discharge, an average of 45 days, 1 year, 3 years
Paraparesis	Rate of patients with New transient (≤ 30 days) paraparesis	At discharge, an average of 45 days, 1 year, 3 years
Malperfusion	Rate of patients with New clinical visceral malperfusion	At discharge, an average of 45 days, 1 year, 3 years
Renal Insufficiency	Rate of patients with New transient (≤ 90 days) renal insufficiency requiring dialysis or hemofiltration	At discharge, an average of 45 days, 1 year, 3 years
Renal Insufficiency	Rate of patients with New permanent (> 90 days) renal insufficiency requiring dialysis or hemofiltration	At discharge, an average of 45 days, 1 year, 3 years
Permeability	Rate of patients with Permeability of the vascular part	1 year, 3 years
Reinterventions	Rate of patients with Reinterventions (device-related, procedure-related, disease-related)	1 year, 3 years
Additional interventions	Rate of patients with Unplanned / planned additional interventions	1 year, 3 year
Bleeding	Re-exploration due to bleeding	At discharge, an average of 45 days, 1 year, 3 years
Endoleaks	Rate of patients with Endoleak type Ib, II, III or IV	At discharge, an average of 45 days, 1 year, 3 years
False Lumen	Rate of patients with Obliterated, completely thrombosed, partially thrombosed, or patent false lumen in the stented region	At discharge, an average of 45 days, 1 year, 3 year
Entry flow	Rate of patients with Type Ib, II or R entry flow, endoleak of unknown origin	At discharge, an average of 45 days, 1 year, 3 year

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Collaborators: ICON plc
• Investigators: Principal Investigator: Olivier Fouquet, Prof, Centre Hospitalo-Universitaire d'Angers

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Aneurysm; Aorta; Trunk; Repair; Open; Thoracic; Dissection; Frozen; Elephant
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: NEO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No