Aortic AneurysmENZENNCT05969782
The Enzen Trial: Comparison of Evar Endoprosthesis: Endurant Versus Zenith
An observational study of Aortic Aneurysm and Aortoiliac Atherosclerosis, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
Trial summary
A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym using Endurant II (Medtronic) or Zenith (Cook). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortoiliac Atherosclerosis
- What is being tested?
- EVAR
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PAtiens with infra-renal aortoiliac aneurysms submitted to EVAR.
Who may be able to join
- -
- Exclusion Criteria: Thoracoabdominal aortic aneurysms, pararenal and supra-renal aortic aneurysms
- Patients not suitable for EVAR.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital do Servidor Público Estadual de São Paulo
São Paulo, São Paulo, 04028-000
About this study
Official title: 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).
Read the 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.
- Conditions
- Aortic Aneurysm, Aortoiliac Atherosclerosis
- Being tested
- EVAR
- Keywords
- aneurysm, aortic, aortic disease
- Medical subject headings
- Aortic Aneurysm, Aneurysm, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVARDevice
Endovascular repair of aortoiliac aneurysm using Zenith or Endurant
| Study group | Role | What they receive |
|---|---|---|
| Endurant II | Patients with aortoiliac aneurysm submitted to EVAR with Endurant II. Receives: Device: EVAR | |
| Zenith | Patients with aortoiliac aneurysm submitted to EVAR with Zenith. Receives: Device: EVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Mortality rate
Mortality rate
Measured: 30 days
Secondary outcomes (2)
Reinterventions
Reinterventions during follow-up
Measured: 2 years
Endoleaks
Endoleaks during follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Servidor Publico Estadual
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael de Athayde Soares, Hospital do Servidor Publico Estadual
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969782
- Sponsor's protocol ID
- 32380920.5.0000.5463
- Acronym
- ENZEN
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Enzen Trial: Comparison of EVAR Outcomes With Endurant Versus Zenith Endoprosthesis: a Prospective Analysis.
- ClinicalTrials.gov ID
- NCT05969782
- Acronym / sponsor ID
- ENZEN / 32380920.5.0000.5463
- Conditions
- Aortic Aneurysm, Aortoiliac Atherosclerosis
- Keywords
- aneurysm, aortic, aortic disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital do Servidor Publico EstadualUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurant II | – | Device: EVARPatients with aortoiliac aneurysm submitted to EVAR with Endurant II. |
| Zenith | – | Device: EVARPatients with aortoiliac aneurysm submitted to EVAR with Zenith. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAtiens with infra-renal aortoiliac aneurysms submitted to EVAR.
Key inclusion criteria (3 listed)
- -
- Exclusion Criteria: Thoracoabdominal aortic aneurysms, pararenal and supra-renal aortic aneurysms
- Patients not suitable for EVAR.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVAREndovascular repair of aortoiliac aneurysm using Zenith or Endurant | Device | Endurant II, Zenith |
Primary outcome
Perioperative Mortality rate
Time frame: 30 days
Mortality rate
2 secondary outcomes
Reinterventions
Time frame: 2 years
Endoleaks
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Aortic Aneurysm
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Clinical Health Outcomes Evaluation of Terumo Aortic Hybrid Devices
Aortic Aneurysm and Dissection
Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Aortoiliac Atherosclerosis, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Mortality rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.