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French Registry Conducted on E-vita OPEN NEO

NCT05721001 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

  • Vascular Aneurysm

Interventions

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.

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • JOTEC GmbH

    lead INDUSTRY

Principal Investigators

  • Olivier Fouquet, Prof · Centre Hospitalo-Universitaire d'Angers

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-11
Primary Completion
2024-03-15
Completion
2027-08-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721001 on ClinicalTrials.gov