Automated Carbon Dioxide Angiography in Fenestrated/Branched Endovascular Abdominal Aortic Aneurysm Repair

Not yet recruiting

• Conditions: Thoracoabdominal Aortic Aneurysm

• Registration Number: NCT06103942
• Lead Sponsor: Uppsala University

Brief Summary

Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent.

Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures.

Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair.

A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term.

The present study will specifically examine the safety of the use of CO2 as intra-arterial contrast agent using the Angiodroid automated CO2-injection system during F/B-EVAR procedures. Furthermore, the current study will focus on image quality during the different steps of the procedure with the aim of standardize injection parameters (volume and pressure) for the detection of the ostium of the visceral vessels as well as of the iliac arteries, all defined as target vessels.

Detailed Description

Carbon Dioxide (CO2)-based angiography is a digital subtraction angiography (DSA), where CO2 is used as an intra-arterial contrast agent. This practice started in 1970s and it is commonly used for patients who have an impaired renal function, allergy to iodinated contrast media (ICM) or that could have a contrast-induced nephropathy (CIN) risk.

Carbon dioxide is an effective and low-risk alternative to ICM, which is nowadays used in endovascular procedures, thanks to its unique properties, such as no risk for nephrotoxicity or allergic reaction. For many years, the two most important restrictions for this technique consisted of: 1) the absence of a delivery system that could minimize the risk of air contamination during the CO2 angiography and allow controlled injection (in terms of pressure and volume of injection) of the CO2 and 2) the absence of a customized imaging protocol for a better visualization of CO2 during DSA acquisition.

Now, with the availability of an automated CO2 injector system (Angiodroid Srl, Italy) and the improvement in image acquisition protocols, CO2 angiography is increasingly used for vascular imaging and endovascular procedures.

Fenestrated and branched endovascular aortic repair (F/B-EVAR) for thoracoabdominal aortic aneurysms (TAAAs) is nowadays considered the treatment of first choice, due to its reduced procedure-related morbidity and mortality, when compared to open repair.

A peculiarity of these procedures is the need of high volumes of contrast media, which are not needed in case of open repair. This increases the related risk of impaired kidney function at the short- and long-term.

The literature on CO2 angiography still lacks on studies regarding the systematic use of the technique in F/B-EVAR procedures.

The present study will specifically examine the safety of the use of CO2 as intra-arterial contrast agent using the Angiodroid automated CO2-injection system during F/B-EVAR procedures. Furthermore, the current study will focus on image quality during the different steps of the procedure with the aim of standardize injection parameters (volume and pressure) for the detection of the ostium of the visceral vessels as well as of the iliac arteries, all defined as target vessels.

The main study hypothesis is that the automated standardized injection of CO2 could provide the same angiographic information and image quality as ICM, which is nowadays used as standard contrast agent in endovascular procedures.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-24
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-27
• Last Update Posted: 2023-10-27
• Study Start: 2023-11-01
• Primary Completion: 2024-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with indication for treatment of complex TAAA according to accepted international guidelines
• Provided informed consent

Exclusion Criteria

• Severe COPD (Chronic Obstructive Pulmonary Disease), GOLD Stage 3 and 4
• Known atrium- or ventricular septal defect with right-left-shunt
• Current participation in other interventional studies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success	at the time the intervention	Technical success in terms of detecting the ostium of the visceral vessels as well as of the hypogastric arteries (defined as 100% accuracy when compared to the iodinated contrast agent angiography)
CO2 sensitivity and specificity compared to iodinated contrast agent angiography	at the time the intervention	CO2 sensitivity and specificity compared to iodinated contrast agent angiography in detecting dissections, stenosis, occlusions or bleeding of the target vessel. The comparison will be blinded and retrospective.

Secondary Outcome Measures

Name	Time	Method
Image quality	at the time the intervention	Image quality with regard to the CO2 angiography defined as poor, moderate and good. The analysis of the images will be retrospective.