French Registry Conducted on E-vita OPEN NEO

Vascular Aneurysm Clinical Trial

— NEO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721001
• Other study ID #: NEO
• Status: Recruiting
• Start date: January 11, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: JOTEC GmbH
• Contact: Emilie Chilaud
• Phone: +49 7471 922 0
• Email: emilie.chilaud[@]artivion.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Vascular Aneurysm

Intervention

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

Country	Name	City	State
France	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 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 Rouen (Charles Nicolle)	Rouen
France	Hopitaux Universtaires Strasbourg	Strasbourg
France	CHU de Tours - Hôpital Trousseau	Tours

Sponsors (2)

Lead Sponsor	Collaborator
JOTEC GmbH	ICON plc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Rate of in-hospital all-cause mortality	through study completion, an average of 3 years
Secondary	Mortality	All-cause mortality	1 year and 3 years
Secondary	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
Secondary	Severe Adverse Events	Rate of patients with SAE until 1 year follow-up (device-related, procedure-related, disease-related)	1 year
Secondary	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
Secondary	Neurological complications	Rate of patients with New permanent (> 30 days) neurological complications	At discharge, an average of 45 days, 1 year, 3 years
Secondary	Neurological complications	Rate of patients with New transient (= 30 days) neurological complications	At discharge, an average of 45 days, 1 year, 3 years
Secondary	Stroke	New permanent (> 30 days) stroke	At discharge, an average of 45 days, 1 year, 3 years
Secondary	Stroke	Rate of patients with New transient (= 30 days) stroke	At discharge, an average of 45 days, 1 year, 3 years
Secondary	Paraplegia	Rate of patients with New permanent (> 30 days) paraplegia	At discharge, an average of 45 days, 1 year, 3 years
Secondary	Paraparesis	Rate of patients with New permanent (> 30 days) paraparesis	At discharge, an average of 45 days, 1 year, 3 years
Secondary	Paraparesis	Rate of patients with New transient (= 30 days) paraparesis	At discharge, an average of 45 days, 1 year, 3 years
Secondary	Malperfusion	Rate of patients with New clinical visceral malperfusion	At discharge, an average of 45 days, 1 year, 3 years
Secondary	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
Secondary	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
Secondary	Permeability	Rate of patients with Permeability of the vascular part	1 year, 3 years
Secondary	Reinterventions	Rate of patients with Reinterventions (device-related, procedure-related, disease-related)	1 year, 3 years
Secondary	Additional interventions	Rate of patients with Unplanned / planned additional interventions	1 year, 3 year
Secondary	Bleeding	Re-exploration due to bleeding	At discharge, an average of 45 days, 1 year, 3 years
Secondary	Endoleaks	Rate of patients with Endoleak type Ib, II, III or IV	At discharge, an average of 45 days, 1 year, 3 years
Secondary	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
Secondary	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