Vascular AneurysmNEONCT05721001
French Registry Conducted on E-vita OPEN NEO
An observational study of Vascular Aneurysm, run by JOTEC GmbH at 23 sites in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Aneurysm
- What is being tested?
- Surgical Repair
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 23 sitesFrance
- Study dates
- 11 Jan 2023to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- non-objection from the patient for data collection within this Registry
- patient treated with E-vita Open NEO
Who cannot join
- objection from the patient for data collection within this Registry
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
CHU Amiens-Picardie
Amiens, 80054
Centre Hospitalo-Universitaire d'Angers
Angers, 49933
Centre Hospitalier Annecy Genevois
Annecy, 74374
CHU Besançon
Besançon, 25030
Clinique Saint-Augustin
Bordeaux, 33074
Hôpital de La Cavale Blanche - Brest
Brest, 29 200
Hôpital Louis PRADEL
Bron, 69677
Hôpital Privé Saint-Martin
Caen, 14000
Clinique de l'Infirmerie Protestante
Caluire-et-Cuire, 69300
Hôpital Gabriel Montpied
Clermont-Ferrand, 63000
Chu Henri Mondor
Créteil, 94010
CHU le Bocage - CHU de Dijon
Dijon, 21079
Hôpital Privé Bois Bernard
Lens, 62320
CHU Lille
Lille, 59000
CHRU Limoges - Dupuytren
Limoges, 87042
CHU Montpellier
Montpellier, 34295
Groupe Hospitalier de la région de Mulhouse et Sud Alsace GHRMSA (Mulhouse)
Mulhouse, 68100
APHP Pitié Salpétrière
Paris, 75013
CHU de Poitiers
Poitiers, 86000
CHU de Rennes - CHRU Pontchaillou
Rennes, 35033
CHU Rouen (Charles Nicolle)
Rouen, 76000
Hopitaux Universtaires Strasbourg
Strasbourg, 67091
CHU de Tours - Hôpital Trousseau
Tours, 37 170
About this study
Official title: 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.
Read the 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
- Conditions
- Vascular Aneurysm
- Being tested
- Surgical Repair
- Keywords
- Thoracic, Aorta, Aneurysm, Dissection, Open, Repair, Frozen, Elephant, Trunk
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical RepairDevice
Also called Frozen Elephant Trunk Technique
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Rate of in-hospital all-cause mortality
Measured: through study completion, an average of 3 years
Secondary outcomes (21)
Mortality
All-cause mortality
Measured: 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
Measured: 1 year and 3 year
Severe Adverse Events
Rate of patients with SAE until 1 year follow-up (device-related, procedure-related, disease-related)
Measured: 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)
Measured: 3 years
Neurological complications
Rate of patients with New permanent (> 30 days) neurological complications
Measured: At discharge, an average of 45 days, 1 year, 3 years
Neurological complications
Rate of patients with New transient (≤ 30 days) neurological complications
Measured: At discharge, an average of 45 days, 1 year, 3 years
Stroke
New permanent (> 30 days) stroke
Measured: At discharge, an average of 45 days, 1 year, 3 years
Stroke
Rate of patients with New transient (≤ 30 days) stroke
Measured: At discharge, an average of 45 days, 1 year, 3 years
Paraplegia
Rate of patients with New permanent (> 30 days) paraplegia
Measured: At discharge, an average of 45 days, 1 year, 3 years
Paraparesis
Rate of patients with New permanent (> 30 days) paraparesis
Measured: At discharge, an average of 45 days, 1 year, 3 years
Paraparesis
Rate of patients with New transient (≤ 30 days) paraparesis
Measured: At discharge, an average of 45 days, 1 year, 3 years
Malperfusion
Rate of patients with New clinical visceral malperfusion
Measured: 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
Measured: 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
Measured: At discharge, an average of 45 days, 1 year, 3 years
Permeability
Rate of patients with Permeability of the vascular part
Measured: 1 year, 3 years
Reinterventions
Rate of patients with Reinterventions (device-related, procedure-related, disease-related)
Measured: 1 year, 3 years
Additional interventions
Rate of patients with Unplanned / planned additional interventions
Measured: 1 year, 3 year
Bleeding
Re-exploration due to bleeding
Measured: At discharge, an average of 45 days, 1 year, 3 years
Endoleaks
Rate of patients with Endoleak type Ib, II, III or IV
Measured: 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
Measured: 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
Measured: At discharge, an average of 45 days, 1 year, 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start11 Jan 2023
- Primary completion15 Mar 2024
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AneurysmStudies of the same condition, open and under way.
- More trials run by JOTEC GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- JOTEC GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Olivier Fouquet, Prof, Principal investigator, Centre Hospitalo-Universitaire d'Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721001
- Sponsor's protocol ID
- NEO
- Acronym
- NEO
- Status last verified
- Mar 2025
- First submitted
- 6 Jan 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEO - E-vita Open Neo Treatment of Aortic Arch Aneurysms and Dissections
- ClinicalTrials.gov ID
- NCT05721001
- Acronym / sponsor ID
- NEO / NEO
- Conditions
- Vascular Aneurysm
- Keywords
- Thoracic, Aorta, Aneurysm, Dissection, Open, Repair, Frozen, Elephant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- JOTEC GmbHIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- non-objection from the patient for data collection within this Registry
- patient treated with E-vita Open NEO
Key exclusion criteria (1 listed)
- objection from the patient for data collection within this Registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical RepairAlso: Frozen Elephant Trunk TechniqueIn 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. | Device | – |
Primary outcome
Mortality
Time frame: through study completion, an average of 3 years
Rate of in-hospital all-cause mortality
21 secondary outcomes
Mortality
Time frame: 1 year and 3 years
Morbidity
Time frame: 1 year and 3 year
Severe Adverse Events
Time frame: 1 year
Severe Adverse Events
Time frame: 3 years
Neurological complications
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Neurological complications
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Stroke
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Stroke
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Paraplegia
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Paraparesis
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Paraparesis
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Malperfusion
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Renal Insufficiency
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Renal Insufficiency
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Permeability
Time frame: 1 year, 3 years
Reinterventions
Time frame: 1 year, 3 years
Additional interventions
Time frame: 1 year, 3 year
Bleeding
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Endoleaks
Time frame: At discharge, an average of 45 days, 1 year, 3 years
False Lumen
Time frame: At discharge, an average of 45 days, 1 year, 3 year
Entry flow
Time frame: At discharge, an average of 45 days, 1 year, 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Fouquet, Prof principal investigator
Centre Hospitalo-Universitaire d'Angers
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Aneurysm, run by JOTEC GmbH at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.