The Enzen Trial: Comparison of Evar Endoprosthesis: Endur... | NCT05969782

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

NCT05969782

Sponsor

Hospital do Servidor Publico Estadual

Status

Unknown status

Last Update Posted

Aug 1, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Aortic Aneurysm
Aortoiliac Atherosclerosis

Interventions

EVAR

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2023Actual

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Sep 1, 2024Estimated

First Submitted Date

Jul 23, 2023

First Submission Date that Met QC Criteria

Jul 23, 2023

First Posted Date

Aug 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2023

Last Update Posted Date

Aug 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rafael de Athayde Soares, MD; PhD, Hospital do Servidor Publico EstadualPrincipal Investigator

Lead Sponsor

Hospital do Servidor Publico EstadualOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endurant II		Patients with aortoiliac aneurysm submitted to EVAR with Endurant II.	Device: EVAR
Zenith		Patients with aortoiliac aneurysm submitted to EVAR with Zenith.	Device: EVAR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EVAR	Device	Endovascular repair of aortoiliac aneurysm using Zenith or Endurant	Endurant II Zenith

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perioperative Mortality rate	Mortality rate	30 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Aortoiliac infra-renal aneurysms.

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

Patients not suitable for EVAR.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

PAtiens with infra-renal aortoiliac aneurysms submitted to EVAR.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital do Servidor Público Estadual de São Paulo		São Paulo	São Paulo	04028-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D001018	Aortic Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided