An observational study in Vascular Aneurysm, sponsored by JOTEC GmbH. Active, not recruiting at 23 sites in France. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by JOTEC GmbH · Observational
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.
Objectives
Primary objective:
Secondary objective:
Morbidity is defined as:
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
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 130 is below the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →JOTEC GmbH is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Also known as: Frozen Elephant Trunk Technique
Mortality
Rate of in-hospital all-cause mortality
Time frame: through study completion, an average of 3 years
Mortality
All-cause mortality
Time frame: 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
Time frame: 1 year and 3 year
Severe Adverse Events
Rate of patients with SAE until 1 year follow-up (device-related, procedure-related, disease-related)
Time frame: 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)
Time frame: 3 years
Neurological complications
Rate of patients with New permanent (\> 30 days) neurological complications
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Neurological complications
Rate of patients with New transient (≤ 30 days) neurological complications
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Stroke
New permanent (\> 30 days) stroke
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Stroke
Rate of patients with New transient (≤ 30 days) stroke
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Paraplegia
Rate of patients with New permanent (\> 30 days) paraplegia
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Paraparesis
Rate of patients with New permanent (\> 30 days) paraparesis
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Paraparesis
Rate of patients with New transient (≤ 30 days) paraparesis
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Malperfusion
Rate of patients with New clinical visceral malperfusion
Time frame: 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
Time frame: 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
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Permeability
Rate of patients with Permeability of the vascular part
Time frame: 1 year, 3 years
Reinterventions
Rate of patients with Reinterventions (device-related, procedure-related, disease-related)
Time frame: 1 year, 3 years
Additional interventions
Rate of patients with Unplanned / planned additional interventions
Time frame: 1 year, 3 year
Bleeding
Re-exploration due to bleeding
Time frame: At discharge, an average of 45 days, 1 year, 3 years
Endoleaks
Rate of patients with Endoleak type Ib, II, III or IV
Time frame: 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
Time frame: 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
Time frame: At discharge, an average of 45 days, 1 year, 3 year
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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JOTEC GmbH