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NCT Number: NCT04299984

Italian Multicenter Database for Open Conversions After EVAR

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Abdominal Aortic Aneurysm Enlargement Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Location status: Recruiting

Location contact

Paolo Perini, MD, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Conversion after EVAR

Procedure

See "Open Conversions" group description.

SemiConversion after EVAR

Procedure

See "SemiConversions" group description.

Primary outcomes

  1. Early Mortality

    Time frame: 30 days

    30-day mortality after surgery

  2. In-hospital Mortality

    Time frame: 90 days

    Mortality during in-hospital stay

  3. Long-term survival

    Time frame: 4 years

    Long-term survival rate

Secondary outcomes

  1. Early Morbidity

    Time frame: 30 days

    Major complications after surgery

  2. Related complications

    Time frame: 4 years

    Aorta-related complications during follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Perini, MD

CONTACT

[email protected]

+390521702349

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Official study title

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

Acronym: iConveRt

Important dates

Study start
2022
Primary completion
2031
Study completion
2032
First posted
Mar 9, 2020
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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