Italian Multicenter Database for Open Conversions After EVAR

Recruiting

• Conditions: Abdominal Aortic Aneurysm Enlargement; Abdominal Aortic Aneurysm

• Registration Number: NCT04299984
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Parma

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Study Start: 2022-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-06-04
• Primary Completion: 2031-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early Mortality	30 days	30-day mortality after surgery
In-hospital Mortality	90 days	Mortality during in-hospital stay
Long-term survival	4 years	Long-term survival rate

Secondary Outcome Measures

Name	Time	Method
Related complications	4 years	Aorta-related complications during follow-up
Early Morbidity	30 days	Major complications after surgery

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria di Parma; 🇮🇹 Parma, Italy