NCT04676672

A PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO

NEOS - A Post-market Clinical Follow-up Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 163 (actual)
• Sponsor: JOTEC GmbH · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The NEOS post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of E-vita OPEN NEO in the treatment of aneurysm or dissection in the ascending aorta, aortic arch and descending thoracic aorta.

Detailed description

In this study, patients will be observed who receive an E-vita OPEN NEO implant for the treatment of thoracic aneurysm or acute or chronic thoracic dissection. E-vita OPEN NEO will be implanted according to the instructions for use and at the discretion of the treating physician. Participating physicians will provide their observations collected during routine care for patients treated with E-vita OPEN NEO. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient prior to data collection. The period of data collection will be approximately 60 months from the date of intervention for each patient. Source data verification will be performed on 100% of the patients; data from all the visits that was provided in the database will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation. All adverse events defined prior to study start will be adjudicated by the Clinical Event Committee (CEC).

Conditions

• Aortic Dissection
• Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Open repair	Open repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft.

Timeline

• Start date: 2020-12-03
• Primary completion: 2023-07-31
• Completion: 2029-06-30
• First posted: 2020-12-21
• Last updated: 2024-01-18

Locations

2 sites across 2 countries: Austria, Germany