Abdominal Aortic AneurysmiConveRtNCT04299984
Italian Multicenter Database for Open Conversions After EVAR
An observational study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm Enlargement, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial summary
Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC). LOC is defined as a total or partial endograft explantation >30 days after the initial EVAR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm Enlargement
- What is being tested?
- Open Conversion after EVAR and SemiConversion after EVAR
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 31 Dec 2032
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent EVAR for abdominal aortic aneurysm exclusion, who developed complications not amenable to endovascular repair.
Who may be able to join
- open or laparoscopic surgery for EVAR complications, with or without endograft explantation
Who cannot join
- endovascular reinterventions
- extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma
Paolo Perini, MD, PhD
About this study
Official title: Italian Multicenter Prospective Database for Open Conversions and SemiConversions After Endovascular Aneurysm Repair
Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC).
LOC is defined as a total or partial endograft explantation >30 days after the initial EVAR.
SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation.
The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.
- Being tested
- Open Conversion after EVAR, SemiConversion after EVAR
- Keywords
- Abdominal aortic aneurysm, Open surgical conversion, Endovascular repair, EVAR explantation, Failed EVAR
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Conversion after EVARProcedure or surgery
See "Open Conversions" group description.
SemiConversion after EVARProcedure or surgery
See "SemiConversions" group description.
| Study group | Role | What they receive |
|---|---|---|
| Open Conversions | Patients undergoing total or partial endograft explantation for any EVAR complication. Receives: Procedure: Open Conversion after EVAR | |
| SemiConversions | Patients undergoing open or laparoscopic surgery for any EVAR complication (mostly endoleak correction) with complete endograft preservation. Receives: Procedure: SemiConversion after EVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Mortality
30-day mortality after surgery
Measured: 30 days
In-hospital Mortality
Mortality during in-hospital stay
Measured: 90 days
Long-term survival
Long-term survival rate
Measured: 4 years
Secondary outcomes (2)
Early Morbidity
Major complications after surgery
Measured: 30 days
Related complications
Aorta-related complications during follow-up
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Jan 2022
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Perini, Azienda Ospedaliero-Universitaria di Parma
- Investigators
- Paolo Perini, MD, Principal investigator, Parma University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299984
- Sponsor's protocol ID
- iConveRt
- Acronym
- iConveRt
- Status last verified
- May 2025
- First submitted
- 5 Mar 2020
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Multicenter Prospective Database for Open Conversions and SemiConversions After Endovascular Aneurysm Repair
- ClinicalTrials.gov ID
- NCT04299984
- Acronym / sponsor ID
- iConveRt / iConveRt
- Keywords
- Abdominal aortic aneurysm, Open surgical conversion, Endovascular repair, EVAR explantation, Failed EVAR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 9 Mar 2020 (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.
Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC).
LOC is defined as a total or partial endograft explantation >30 days after the initial EVAR.
SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation.
The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Conversions | – | Procedure: Open Conversion after EVARPatients undergoing total or partial endograft explantation for any EVAR complication. |
| SemiConversions | – | Procedure: SemiConversion after EVARPatients undergoing open or laparoscopic surgery for any EVAR complication (mostly endoleak correction) with complete endograft preservation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent EVAR for abdominal aortic aneurysm exclusion, who developed complications not amenable to endovascular repair.
Key inclusion criteria (1 listed)
- open or laparoscopic surgery for EVAR complications, with or without endograft explantation
Key exclusion criteria (2 listed)
- endovascular reinterventions
- extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft surgery
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 |
|---|---|---|
| Open Conversion after EVARSee "Open Conversions" group description. | Procedure or surgery | Open Conversions |
| SemiConversion after EVARSee "SemiConversions" group description. | Procedure or surgery | SemiConversions |
Primary outcome
Early Mortality
Time frame: 30 days
30-day mortality after surgery
In-hospital Mortality
Time frame: 90 days
Mortality during in-hospital stay
Long-term survival
Time frame: 4 years
Long-term survival rate
2 secondary outcomes
Early Morbidity
Time frame: 30 days
Related complications
Time frame: 4 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 4 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Paolo Perini, MD principal investigator
Parma University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Abdominal Aortic Aneurysm Enlargement, run by Azienda Ospedaliero-Universitaria di Parma at 1 site 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Paolo Perini, MD (+390521702349, p.perini@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Mortality (time frame: 30 days). The study lists 3 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 4 Jun 2025; AzTrials last refreshed its copy on 29 Oct 2026.