Italian Multicenter Database for Open Conversions After EVAR | NCT04299984

Studies
Italian Multicenter Database for Open Conversions After EVAR

NCT04299984

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Status

Recruiting

Last Update Posted

Jun 4, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Enlargement

Interventions

Open Conversion after EVAR
SemiConversion after EVAR

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2031Estimated

Completion Date

Dec 31, 2032Estimated

First Submitted Date

Mar 5, 2020

First Submission Date that Met QC Criteria

Mar 5, 2020

First Posted Date

Mar 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2025

Last Update Posted Date

Jun 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paolo Perini, MD, PhD, Azienda Ospedaliero-Universitaria di ParmaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliero-Universitaria di ParmaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Open Conversion after EVAR	Procedure	See "Open Conversions" group description.	Open Conversions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Early Morbidity	Major complications after surgery	30 days
Related complications	Aorta-related complications during follow-up	4 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paolo Perini, MD	Contact	+390521702349		p.perini@live.com

Overall Officials

Name	Affiliation	Role
Paolo Perini, MD	Parma University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliero-Universitaria di Parma	Recruiting	Parma			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided