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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04721951
Acronym
CO2-EVAR
Enrollment
65
Registered
2021-01-25
Start date
2018-12-12
Completion date
2022-01-26
Last updated
2022-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm

Keywords

Endovascular Aortic Repair

Brief summary

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

Interventions

PROCEDUREEndovascular Aortic Repair using Carbon Dioxide Angiography

Endovascular Aortic Repair using Carbon Dioxide Angiography

Sponsors

University of Bologna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Technical Success30 DaysTechnical 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

MeasureTime frameDescription
Image Quality30 DaysImage quality for guiding the procedure defined as good for stent-graft implantation or low not allowing stent-graft implantation
Endoleak Detection30 DaysType I-IV endoleak detection
CO2 Quantity30 DaysAmount of CO2 at each deployment step (renal arteries, right/left hypogastric artery, final angiography)
Aneurysm Exclusion30 DaysAneurysm exclusion without type I or III endoleaks at the CT scan at discharge
Adverse Events30 DaysAny adverse event within 24 hours

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026