Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
130 participants
OBSERVATIONAL
2023-01-11
2027-08-31
Brief Summary
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Primary objective is evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic pathologies with E-vita OPEN NEO.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
OTHER
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patient treated with E-vita Open NEO
Exclusion Criteria
ALL
No
Sponsors
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ICON plc
INDUSTRY
JOTEC GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Olivier Fouquet, Prof
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalo-Universitaire d'Angers
Locations
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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
Countries
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Other Identifiers
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NEO
Identifier Type: -
Identifier Source: org_study_id
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