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Italian Multicenter Database for Open Conversions After EVAR

ConditionsAbdominal Aortic AneurysmAbdominal Aortic Aneurysm Enlargement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria di Parma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

open or laparoscopic surgery for EVAR complications, with or without endograft explantation

Disqualifiers

endovascular reinterventions

extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft surgery

Trial population

Patients who underwent EVAR for abdominal aortic aneurysm exclusion, who developed complications not amenable to endovascular repair.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Open Conversion after EVAR

    Procedure/Surgery

    See "Open Conversions" group description.

  • SemiConversion after EVAR

    Procedure/Surgery

    See "SemiConversions" group description.

Treatment groups

500 Participants
are divided into 2 treatment groups
Group A: Open Conversions1 intervention
Group B: SemiConversions1 intervention

Trial outcomes

Primary outcomes

1

Early Mortality

30-day mortality after surgery

Time frame
30 days
2

In-hospital Mortality

Mortality during in-hospital stay

Time frame
90 days
3

Long-term survival

Long-term survival rate

Time frame
4 years

Secondary outcomes

1

Early Morbidity

Major complications after surgery

Time frame
30 days
2

Related complications

Aorta-related complications during follow-up

Time frame
4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero-Universitaria di Parma

Lead sponsor

Source ClinicalTrials.gov
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