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

Active, not recruiting

• Conditions: Aortoiliac Atherosclerosis; Aortic Aneurysm

• Registration Number: NCT05969782
• Lead Sponsor: Hospital do Servidor Publico Estadual

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted: 2023-07-23
• Study First Submitted QC: 2023-07-23
• Last Update Submitted: 2023-07-23
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Aortoiliac infra-renal aneurysms.

Exclusion Criteria

Thoracoabdominal aortic aneurysms, pararenal and supra-renal aortic aneurysms

• Patients not suitable for EVAR.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative Mortality rate	30 days	Mortality rate

Secondary Outcome Measures

Name	Time	Method
Reinterventions	2 years	Reinterventions during follow-up
Endoleaks	2 years	Endoleaks during follow-up

Trial Locations

Locations (1)

Hospital do Servidor Público Estadual de São Paulo; 🇧🇷 São Paulo, SP, Brazil