French Registry Conducted on E-vita OPEN NEO

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Mortality — through study completion, an average of 3 years
  Rate of in-hospital all-cause mortality

Trial sites (23)