Italian Multicenter Database for Open Conversions After EVAR

Abdominal Aortic Aneurysm Clinical Trial

— iConveRt  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04299984
• Other study ID #: iConveRt
• Status: Not yet recruiting
• Start date: August 1, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: July 2020
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: Paolo Perini, MD
• Phone: +390521702349
• Email: p.perini[@]live.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Abdominal Aortic Aneurysm Enlargement
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early Mortality	30-day mortality after surgery	30 days
Primary	In-hospital Mortality	Mortality during in-hospital stay	90 days
Primary	Long-term survival	Long-term survival rate	4 years
Secondary	Early Morbidity	Major complications after surgery	30 days
Secondary	Related complications	Aorta-related complications during follow-up	4 years