Vascular Aneurysm
Conditions
Keywords
Thoracic, Aorta, Aneurysm, Dissection, Open, Repair, Frozen, Elephant, Trunk
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
Interventions
DEVICESurgical 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.
Sponsors
ICON plc
JOTEC GmbH
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | through study completion, an average of 3 years | Rate of in-hospital all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Severe Adverse Events | 1 year | Rate of patients with SAE until 1 year follow-up (device-related, procedure-related, disease-related) |
| Neurological complications | At discharge, an average of 45 days, 1 year, 3 years | Rate of patients with New permanent (\> 30 days) neurological complications |
| Stroke | At discharge, an average of 45 days, 1 year, 3 years | New permanent (\> 30 days) stroke |
| Paraplegia | At discharge, an average of 45 days, 1 year, 3 years | Rate of patients with New permanent (\> 30 days) paraplegia |
| Paraparesis | At discharge, an average of 45 days, 1 year, 3 years | Rate of patients with New permanent (\> 30 days) paraparesis |
| Malperfusion | At discharge, an average of 45 days, 1 year, 3 years | Rate of patients with New clinical visceral malperfusion |
| Mortality | 1 year and 3 years | All-cause mortality |
| Permeability | 1 year, 3 years | Rate of patients with Permeability of the vascular part |
| Reinterventions | 1 year, 3 years | Rate of patients with Reinterventions (device-related, procedure-related, disease-related) |
| Additional interventions | 1 year, 3 year | Rate of patients with Unplanned / planned additional interventions |
| Bleeding | At discharge, an average of 45 days, 1 year, 3 years | Re-exploration due to bleeding |
| Endoleaks | At discharge, an average of 45 days, 1 year, 3 years | Rate of patients with Endoleak type Ib, II, III or IV |
| 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 |
| 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 |
| Renal Insufficiency | At discharge, an average of 45 days, 1 year, 3 years | Rate of patients with New transient (≤ 90 days) renal insufficiency requiring dialysis or hemofiltration |
Countries
France
Outcome results
None listed