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

Active, not recruiting

• Conditions: Aortoiliac Atherosclerosis; Aortic Aneurysm
• Interventions: Device: EVAR

• 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

Arm && Interventions

Group	Intervention	Description
Endurant II	EVAR	Patients with aortoiliac aneurysm submitted to EVAR with Endurant II.
Zenith	EVAR	Patients with aortoiliac aneurysm submitted to EVAR with Zenith.

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