Menu
Recruiting NCT04299984

Italian Multicenter Database for Open Conversions After EVAR

Observational Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm Enlargement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Open Conversion after EVAR, SemiConversion after EVAR.
Who it may be relevant to
Registry conditions: Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm Enlargement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Italian Multicenter Prospective Database for Open Conversions and SemiConversions After Endovascular Aneurysm Repair

Overview

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.

Interventions

  • Procedure Open Conversion after EVAR
    See "Open Conversions" group description.
  • Procedure SemiConversion after EVAR
    See "SemiConversions" group description.

Primary outcome measures

  • Early Mortality [Time frame: 30 days]
  • In-hospital Mortality [Time frame: 90 days]
  • Long-term survival [Time frame: 4 years]
Secondary outcome measures (2)
  • Early Morbidity [Time frame: 30 days]
  • Related complications [Time frame: 4 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Azienda Ospedaliero-Universitaria di Parma — Parma

Identifiers

NCT: NCT04299984 · iConveRt

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗