Italian Multicenter Database for Open Conversions After EVAR

NCT ID: NCT04299984

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2032-12-31

Brief Summary

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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

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Conditions

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Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm Enlargement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Open Conversions

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

Open Conversion after EVAR

Intervention Type PROCEDURE

See "Open Conversions" group description.

SemiConversions

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

SemiConversion after EVAR

Intervention Type PROCEDURE

See "SemiConversions" group description.

Interventions

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Open Conversion after EVAR

See "Open Conversions" group description.

Intervention Type PROCEDURE

SemiConversion after EVAR

See "SemiConversions" group description.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role lead

Responsible Party

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Paolo Perini

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paolo Perini, MD

Role: PRINCIPAL_INVESTIGATOR

Parma University Hospital

Locations

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Azienda Ospedaliero-Universitaria di Parma

Parma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Perini, MD

Role: CONTACT

+390521702349

Facility Contacts

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Paolo Perini, MD, PhD

Role: primary

Other Identifiers

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iConveRt

Identifier Type: -

Identifier Source: org_study_id

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