French Registry Conducted on E-vita OPEN NEO
- Conditions
- Vascular Aneurysm
- Registration Number
- NCT05721001
- Lead Sponsor
- JOTEC GmbH
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- non-objection from the patient for data collection within this Registry
- patient treated with E-vita Open NEO
- objection from the patient for data collection within this Registry
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality through study completion, an average of 3 years Rate of in-hospital all-cause mortality
- Secondary Outcome Measures
Name Time Method Mortality 1 year and 3 years All-cause mortality
Neurological complications At discharge, an average of 45 days, 1 year, 3 years Rate of patients with New transient (≤ 30 days) neurological complications
Reinterventions 1 year, 3 years Rate of patients with Reinterventions (device-related, procedure-related, disease-related)
Severe Adverse Events 3 years Rate of patients with SAE between 1 year and 3 year year follow-up (device-related, procedure-related, disease-related)
Stroke At discharge, an average of 45 days, 1 year, 3 years Rate of patients with New transient (≤ 30 days) stroke
Paraplegia At discharge, an average of 45 days, 1 year, 3 years Rate of patients with New permanent (\> 30 days) paraplegia
Renal Insufficiency At discharge, an average of 45 days, 1 year, 3 years Rate of patients with New permanent (\> 90 days) renal insufficiency requiring dialysis or hemofiltration
Entry flow At discharge, an average of 45 days, 1 year, 3 year Rate of patients with Type Ib, II or R entry flow, endoleak of unknown origin
Morbidity 1 year and 3 year 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
Paraparesis At discharge, an average of 45 days, 1 year, 3 years Rate of patients with New transient (≤ 30 days) paraparesis
Permeability 1 year, 3 years Rate of patients with Permeability of the vascular part
Endoleaks At discharge, an average of 45 days, 1 year, 3 years Rate of patients with Endoleak type Ib, II, III or IV
Malperfusion At discharge, an average of 45 days, 1 year, 3 years Rate of patients with New clinical visceral malperfusion
Bleeding At discharge, an average of 45 days, 1 year, 3 years Re-exploration due to bleeding
False Lumen At discharge, an average of 45 days, 1 year, 3 year Rate of patients with Obliterated, completely thrombosed, partially thrombosed, or patent false lumen in the stented region
Additional interventions 1 year, 3 year Rate of patients with Unplanned / planned additional interventions
Trial Locations
- Locations (23)
Chu Henri Mondor
🇫🇷Créteil, France
CHU de Poitiers
🇫🇷Poitiers, France
CHU de Rennes - CHRU Pontchaillou
🇫🇷Rennes, 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
Hôpital Privé Bois Bernard
🇫🇷Lens, France
Clinique de l'Infirmerie Protestante
🇫🇷Caluire-et-Cuire, France
Hôpital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
CHU le Bocage - CHU de Dijon
🇫🇷Dijon, France
CHU Montpellier
🇫🇷Montpellier, France
CHU Lille
🇫🇷Lille, France
CHRU Limoges - Dupuytren
🇫🇷Limoges, 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, France