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

Completed

• Conditions: Abdominal Aortic Aneurysm

• Registration Number: NCT04721951
• Lead Sponsor: University of Bologna

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-12
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-25
• Primary Completion: 2021-12-31
• Status Verified: 2022-01
• Study Completion: 2022-01-26
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Success	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of experimental diagnostic and specialty medicine - Vascular Surgery; 🇮🇹 Bologna, Italy