NCT06946381

Brief Summary

Spontaneus Multicentric Observational registry to investigate the medium and long-term performances of the Iliac E-liac Branch Device from Artivion for treatment of Aortoiliac aneurysms in a real-world consecutive patients cohort.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress87%
Jan 2015Jan 2028

Study Start

First participant enrolled

January 1, 2015

Completed
10.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 27, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

11 years

First QC Date

April 9, 2025

Last Update Submit

April 23, 2025

Conditions

Aortoiliac AneurysmIliac Aneurysm

Keywords

evarbevarAAA

Outcome Measures

Primary Outcomes (2)

  • Aneurysm related death

    Aneurysm related death

    assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years.

  • Procedure-related re intervention

    Procedure-related re intervention

    assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years

Secondary Outcomes (1)

  • Aneurysm sac dynamics

    assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years

Study Arms (1)

MAIN

Consecutive patients treated with the e-liac device

Procedure: Evar

Interventions

EvarPROCEDURE

Branch Evar with the e-liac device

MAIN

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients feferred to the insitution

You may qualify if:

  • An aortoiliac or aortic aneurysm of surgical interest based on the most recent local guidelines treated with the E-liac stent-graft system, alone or in combination with other devices

You may not qualify if:

  • Patient's refusal to be enrolled in the registry
  • Patient treated with devices not including the E-liac stent-graft system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Azienda ospedaliero-universitaria consorziale policlinico di Bari

Bari, BA, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II

Naples, Italy

RECRUITING

MeSH Terms

Conditions

Iliac Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular Diseases

Central Study Contacts

Umberto Marcello UM Bracale, PhD, Prof.

CONTACT

081 746 2629chirurgiavascolarefedericoii@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 27, 2025

Study Start

January 1, 2015

Primary Completion

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

April 27, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)