NCT05969782

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 23, 2023

Last Update Submit

July 23, 2023

Conditions

Aortic AneurysmAortoiliac Atherosclerosis

Keywords

aneurysmaorticaortic disease

Outcome Measures

Primary Outcomes (1)

  • Perioperative Mortality rate

    Mortality rate

    30 days

Secondary Outcomes (2)

  • Reinterventions

    2 years

  • Endoleaks

    2 years

Study Arms (2)

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

EVARDEVICE

Endovascular repair of aortoiliac aneurysm using Zenith or Endurant

Endurant IIZenith

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PAtiens with infra-renal aortoiliac aneurysms submitted to EVAR.

You may not qualify if:

  • Patients not suitable for EVAR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Servidor Público Estadual de São Paulo

São Paulo, São Paulo, 04028-000, Brazil

Location

MeSH Terms

Conditions

Aortic AneurysmAneurysmAortic Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD; PhD

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)