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
-
-
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.
|
Endovascular repair of aortoiliac aneurysm using Zenith or Endurant
|
|
Zenith
Patients with aortoiliac aneurysm submitted to EVAR with Zenith.
|
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.
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.