Skip to main content
OpenTrials
Completed

NCT Number: NCT04721951

An Innovative Approach to Automated Carbon Dioxide Angiography During Endovascular Abdominal Aortic Aneurysm Repair

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Aortic Aneurysm 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

Department of experimental diagnostic and specialty medicine - Vascular Surgery

Bologna, 40138, Italy

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Endovascular Aortic Repair using Carbon Dioxide Angiography

Procedure

Endovascular Aortic Repair using Carbon Dioxide Angiography

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. Endoleak Detection

    Time frame: 30 Days

    Type I-IV endoleak detection

  3. CO2 Quantity

    Time frame: 30 Days

    Amount of CO2 at each deployment step (renal arteries, right/left hypogastric artery, final angiography)

  4. Aneurysm Exclusion

    Time frame: 30 Days

    Aneurysm exclusion without type I or III endoleaks at the CT scan at discharge

  5. Adverse Events

    Time frame: 30 Days

    Any adverse event within 24 hours

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Acronym: CO2-EVAR

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jan 25, 2021
Registry last updated
Jan 28, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.