Aortoiliac AneurysmCAMPARINCT06946381
CAMpania PugliA bRanch Iliaco
An observational study of Aortoiliac Aneurysm and Iliac Aneurysm, run by Federico II University at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortoiliac Aneurysm, Iliac Aneurysm
- What is being tested?
- Evar
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jan 2015to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients feferred to the insitution
Who may be able to join
- 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
Who cannot join
- Patient's refusal to be enrolled in the registry
- Patient treated with devices not including the E-liac stent-graft system
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Azienda ospedaliero-universitaria consorziale policlinico di Bari
Bari, BA
Domenico D Angiletta, PhD, Prof., + 39 080 559 1111, domenico.angiletta@uniba.it
- Recruiting
Azienda Ospedaliera Universitaria Federico II
Naples
Umberto Marcello UM Bracale, PhD, Prof, + 39 081 746 2629, chirurgiavascolarefedericoii@gmail.com
About this study
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.
- Conditions
- Aortoiliac Aneurysm, Iliac Aneurysm
- Being tested
- Evar
- Keywords
- evar, bevar, AAA
- Medical subject headings
- Iliac Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvarProcedure or surgery
Branch Evar with the e-liac device
| Study group | Role | What they receive |
|---|---|---|
| MAIN | Consecutive patients treated with the e-liac device Receives: Procedure: Evar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysm related death
Aneurysm related death
Measured: 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
Measured: assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years
Secondary outcomes (1)
Aneurysm sac dynamics
Variation in aneurysm sac diameter
Measured: assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jan 2015
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortoiliac AneurysmStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari
- Responsible party
- Principal investigator, Umberto Marcello Bracale, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946381
- Sponsor's protocol ID
- CAMPARI
- Acronym
- CAMPARI
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMpania PugliA bRanch Iliaco
- ClinicalTrials.gov ID
- NCT06946381
- Acronym / sponsor ID
- CAMPARI / CAMPARI
- Conditions
- Aortoiliac Aneurysm, Iliac Aneurysm
- Keywords
- evar, bevar, AAA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- University of Bari
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 27 Apr 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAIN | – | Procedure: EvarConsecutive patients treated with the e-liac device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients feferred to the insitution
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Patient's refusal to be enrolled in the registry
- Patient treated with devices not including the E-liac stent-graft system
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 |
|---|---|---|
| EvarBranch Evar with the e-liac device | Procedure or surgery | MAIN |
Primary outcome
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
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
1 secondary outcome
Aneurysm sac dynamics
Time frame: assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Aortoiliac Aneurysm
RecruitingObservational study
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD)
RecruitingPhase 4
Liposomal Bupivacaine/Bupivacaine in Rectus Sheath Blocks Versus Ropivacaine in Rectus Sheath Blocks And Catheters
Aortic Aneurysm, Abdominal, Abdominal Aortic Occlusion
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortoiliac Aneurysm and Iliac Aneurysm, run by Federico II University at 2 sites in Italy.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umberto Marcello UM Bracale, PhD, Prof. (081 746 2629, chirurgiavascolarefedericoii@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aneurysm related death (time frame: assessed after procedure at 30 days, 6 months, one year, two years, three years, four years, five years.). The study lists 2 primary outcomes in all. 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 27 Apr 2025.