CAMpania PugliA bRanch Iliaco (CAMPARI)

April 23, 2025 updated by: Umberto Marcello Bracale, Federico II University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Naples, Italy
    • BA
      • Bari, BA, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients feferred to the insitution

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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
MAIN
Consecutive patients treated with the e-liac device
Procedure: Evar
Branch Evar with the e-liac device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aneurysm related death
Time Frame: assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years.
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
Time Frame: assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years
Procedure-related re intervention
assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aneurysm sac dynamics
Time Frame: assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years
Variation in aneurysm sac diameter
assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Collaborators

University of Bari

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)

January 1, 2015

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMPARI

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.

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