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

Abdominal Aortic Aneurysm Clinical Trial

— CO2-EVAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721951
• Other study ID #: CO2-EVAR
• Status: Completed
• Start date: December 12, 2018
• Est. completion date: January 26, 2022

Study information

• Verified date: January 2022
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 26, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Procedure:
• Endovascular Aortic Repair using Carbon Dioxide Angiography
Endovascular Aortic Repair using Carbon Dioxide Angiography

Locations

Country	Name	City	State
Italy	Department of experimental diagnostic and specialty medicine - Vascular Surgery	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

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