NCT05721001

French Registry Conducted on E-vita OPEN NEO

NEO - E-vita Open Neo Treatment of Aortic Arch Aneurysms and Dissections

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: JOTEC GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Vascular Aneurysm

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-01-11
• Primary completion: 2024-03-15
• Completion: 2027-08-31
• First posted: 2023-02-09
• Last updated: 2025-03-28

Locations

23 sites across 1 country: France