The Enzen Trial: Comparison of Evar Endoprosthesis: Endurant Versus Zenith (ENZEN)

July 23, 2023 updated by: Rafael de Athayde Soares, Hospital do Servidor Publico Estadual

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04028-000
        • Hospital do Servidor Publico Estadual de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

PAtiens with infra-renal aortoiliac aneurysms submitted to EVAR.

Description

Inclusion Criteria: Aortoiliac infra-renal aneurysms.

-

Exclusion Criteria: Thoracoabdominal aortic aneurysms, pararenal and supra-renal aortic aneurysms

  • Patients not suitable for EVAR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endurant II
Patients with aortoiliac aneurysm submitted to EVAR with Endurant II.
Device: EVAR
Endovascular repair of aortoiliac aneurysm using Zenith or Endurant
Zenith
Patients with aortoiliac aneurysm submitted to EVAR with Zenith.
Device: EVAR
Endovascular repair of aortoiliac aneurysm using Zenith or Endurant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Mortality rate
Time Frame: 30 days
Mortality rate
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reinterventions
Time Frame: 2 years
Reinterventions during follow-up
2 years
Endoleaks
Time Frame: 2 years
Endoleaks during follow-up
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Servidor Publico Estadual

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32380920.5.0000.5463

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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