Clinical trial NCT05721001: French Registry Conducted on E-vita OPEN NEO
Official title: NEO - E-vita Open Neo Treatment of Aortic Arch Aneurysms and Dissections
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vascular Aneurysm
Keywords: Thoracic
Aorta
Aneurysm
Dissection
Open
Repair
Frozen
Elephant
Trunk
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2023-02-09
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Mortality
timeFrame: 1 year and 3 years
measure: Morbidity
timeFrame: 1 year and 3 year
measure: Severe Adverse Events
timeFrame: 1 year
measure: Severe Adverse Events
timeFrame: 3 years
measure: Neurological complications
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Neurological complications
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Stroke
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Stroke
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Paraplegia
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Paraparesis
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Paraparesis
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Malperfusion
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Renal Insufficiency
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Renal Insufficiency
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Permeability
timeFrame: 1 year, 3 years
measure: Reinterventions
timeFrame: 1 year, 3 years
measure: Additional interventions
timeFrame: 1 year, 3 year
measure: Bleeding
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: Endoleaks
timeFrame: At discharge, an average of 45 days, 1 year, 3 years
measure: False Lumen
timeFrame: At discharge, an average of 45 days, 1 year, 3 year
measure: Entry flow
timeFrame: At discharge, an average of 45 days, 1 year, 3 year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Angers
country: France
facility: Centre Hospitalo-Universitaire d'Angers
city: Annecy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: Clinique Saint-Augustin
city: Brest
country: France
facility: Hôpital de La Cavale Blanche - Brest
city: Bron
country: France
facility: Hôpital Louis PRADEL
city: Caen
country: France
facility: Hôpital Privé Saint-Martin
city: Caluire-et-Cuire
country: France
facility: Clinique de l'Infirmerie Protestante
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Créteil
country: France
facility: Chu Henri Mondor
city: Dijon
country: France
facility: CHU le Bocage - CHU de Dijon
city: Lens
country: France
facility: Hôpital Privé Bois Bernard
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: CHRU Limoges - Dupuytren
city: Montpellier
country: France
facility: CHU Montpellier
city: Mulhouse
country: France
facility: Groupe Hospitalier de la région de Mulhouse et Sud Alsace GHRMSA (Mulhouse)
city: Paris
country: France
facility: APHP Pitié Salpétrière
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes - CHRU Pontchaillou
city: Rouen
country: France
facility: CHU Rouen (Charles Nicolle)
city: Strasbourg
country: France
facility: Hopitaux Universtaires Strasbourg
city: Tours
country: France
facility: CHU de Tours - Hôpital Trousseau
Study officials:
affiliation: Centre Hospitalo-Universitaire d'Angers
name: Olivier Fouquet, Prof
role: PRINCIPAL_INVESTIGATOR
References: