Italian Multicenter Database for Open Conversions After EVAR

NCT04299984 | Recruiting

• 1 other identifier: iConveRt
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm Enlargement

Keywords

Abdominal aortic aneurysm; Open surgical conversion; Endovascular repair; EVAR explantation; Failed EVAR

Outcome Measures

Primary Outcomes (3)

• Early Mortality

  30-day mortality after surgery

  30 days

• In-hospital Mortality

  Mortality during in-hospital stay

  90 days

• Long-term survival

  Long-term survival rate

  4 years

Secondary Outcomes (2)

• Early Morbidity

  30 days

• Related complications

  4 years

Study Arms (2)

Open Conversions

Patients undergoing total or partial endograft explantation for any EVAR complication.

Procedure: Open Conversion after EVAR

SemiConversions

Patients undergoing open or laparoscopic surgery for any EVAR complication (mostly endoleak correction) with complete endograft preservation.

Procedure: SemiConversion after EVAR

Interventions

Open Conversion after EVAR PROCEDURE

See "Open Conversions" group description.

Open Conversions

SemiConversion after EVAR PROCEDURE

See "SemiConversions" group description.

SemiConversions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Paolo Perini, MD

  Parma University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Perini, MD

CONTACT

+390521702349; p.perini@live.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)