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NCT05969782 Clinical Trial

The Enzen Trial: Comparison of Evar Endoprosthesis: Endurant Versus Zenith

Aortic Aneurysm Clinical Trial

— ENZEN  

Official title:
The Enzen Trial: Comparison of EVAR Outcomes With Endurant Versus Zenith Endoprosthesis: a Prospective Analysis.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05969782
Other study ID # 32380920.5.0000.5463
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date September 1, 2024

Study information
Verified date July 2023
Source Hospital do Servidor Publico Estadual
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym using Endurant II (Medtronic) or Zenith (Cook).

Description:

A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym using Endurant II (Medtronic) or Zenith (Cook). The patients will be evaluated in a follow-up, regarding overall mortality rate, perioperative mortality rate and outcomes, such as Endoleaks and reinterventions.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date September 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: Aortoiliac infra-renal aneurysms. - Exclusion Criteria: Thoracoabdominal aortic aneurysms, pararenal and supra-renal aortic aneurysms - Patients not suitable for EVAR.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• EVAR
Endovascular repair of aortoiliac aneurysm using Zenith or Endurant

Locations
Country Name City State
Brazil Hospital do Servidor Público Estadual de São Paulo São Paulo SP

Sponsors (1)
Lead Sponsor Collaborator
Hospital do Servidor Publico Estadual

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perioperative Mortality rate Mortality rate 30 days
Secondary Reinterventions Reinterventions during follow-up 2 years
Secondary Endoleaks Endoleaks during follow-up 2 years
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