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

NCT ID: NCT05969782

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Aortic Aneurysm Aortoiliac Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endurant II

Patients with aortoiliac aneurysm submitted to EVAR with Endurant II.

EVAR

Intervention Type DEVICE

Endovascular repair of aortoiliac aneurysm using Zenith or Endurant

Zenith

Patients with aortoiliac aneurysm submitted to EVAR with Zenith.

EVAR

Intervention Type DEVICE

Endovascular repair of aortoiliac aneurysm using Zenith or Endurant

Interventions

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EVAR

Endovascular repair of aortoiliac aneurysm using Zenith or Endurant

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Patients not suitable for EVAR.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital do Servidor Publico Estadual

OTHER

Sponsor Role lead

Responsible Party

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Rafael de Athayde Soares

MD; PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital do Servidor Público Estadual de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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32380920.5.0000.5463

Identifier Type: -

Identifier Source: org_study_id

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