An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair (CO2-EVAR)

January 27, 2022 updated by: Andrea Vacirca, University of Bologna

CO2-EVAR - An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair - (Proof of Concept Study)

The study aims to perform Endovascular Aortic Repair procedures with CO2-Angiography using a standardized an operative Protocol

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

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

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Department of experimental diagnostic and specialty medicine - Vascular Surgery

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with AAA, undergoing EVAR

Description

Inclusion Criteria:

  • Age > 18 years
  • Male, female
  • Patients with indication for AAA
  • Informed consent achievement

Exclusion Criteria:

  • Severe COPD (Chronic Obstructive Pulmonary Disease)
  • Known atrium- or ventricular septal defect with right-left-shunt
  • Severe renal arteries atherosclerosis
  • Ruptured AAA
  • Current partecipation in other interventional studies

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: 30 Days
Technical success to assess the renal ostia and the hypogastric arteries (defined as 100% accuracy correlated to the iodinated contrast agent angiography or IVUS/FUSION techniques)
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality
Time Frame: 30 Days
Image quality for guiding the procedure defined as good for stent-graft implantation or low not allowing stent-graft implantation
30 Days
Endoleak Detection
Time Frame: 30 Days
Type I-IV endoleak detection
30 Days
CO2 Quantity
Time Frame: 30 Days
Amount of CO2 at each deployment step (renal arteries, right/left hypogastric artery, final angiography)
30 Days
Aneurysm Exclusion
Time Frame: 30 Days
Aneurysm exclusion without type I or III endoleaks at the CT scan at discharge
30 Days
Adverse Events
Time Frame: 30 Days
Any adverse event within 24 hours
30 Days

Collaborators and Investigators

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

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Mauro Gargiulo, Prof, Department of experimental diagnostic and specialty medicine - Vascular Surgery - University of Bologna

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 (Actual)

December 12, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

January 26, 2022

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO2-EVAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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