Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103942
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-27
First Post:
2023-10-18
Brief Title:
Automated Carbon Dioxide Angiography in FenestratedBranched Endovascular Abdominal Aortic Aneurysm Repair
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Automated Carbon Dioxide Angiography in Comparison to Iodinated Contrast Medium Angiography During FenestratedBranched Endovascular Abdominal Aortic Aneurysm Repair FB-EVAR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 FB-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 FB-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
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 FB-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 FB-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 FB-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 FB-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 FB-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
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 FB-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 FB-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 FB-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None