Italian Multicenter Database for Open Conversions After EVAR (iConveRt)

July 7, 2020 updated by: Paolo Perini, Azienda Ospedaliero-Universitaria di Parma

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Conversions
Patients undergoing total or partial endograft explantation for any EVAR complication.
Procedure: Open Conversion after EVAR
See "Open Conversions" group description.
SemiConversions
Patients undergoing open or laparoscopic surgery for any EVAR complication (mostly endoleak correction) with complete endograft preservation.
Procedure: SemiConversion after EVAR
See "SemiConversions" group description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Mortality
Time Frame: 30 days
30-day mortality after surgery
30 days
In-hospital Mortality
Time Frame: 90 days
Mortality during in-hospital stay
90 days
Long-term survival
Time Frame: 4 years
Long-term survival rate
4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Investigators

  • Principal Investigator: Paolo Perini, MD, Parma University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

December 31, 2029

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

March 5, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iConveRt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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