Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05304026
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2022-03-03
Brief Title:
Optimizing CO2 Injection Technique for EVAR
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Optimizing CO2 Injection Technique for Renal Artery Detection in Endovascular Abdominal Aortic Aneurysm Repair
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
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:
Automated carbon dioxide CO2 angiography is considered a safe diagnostic alternative to standard iodinated contrast medium ICM for endovascular aortic repair EVAR of abdominal aortic aneurysm AAA especially in patients with preoperative renal function impairment
Recent literature experiences describe the use of automated CO2 angiography in EVAR
One of the main issues of CO2 angiography is the inability to detect the origin of the lowest renal artery proximal neck visualization that was estimated up to 38
In these experiences the CO2 automated angiography is usually performed by a 5F pigtail catheter placed at renal arteries level
The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique by a 5F introducer single hole catheter positioned at the distal level of the proximal neck in detecting both renal arteries in the first diagnostic and completion angiographies
Recent literature experiences describe the use of automated CO2 angiography in EVAR
One of the main issues of CO2 angiography is the inability to detect the origin of the lowest renal artery proximal neck visualization that was estimated up to 38
In these experiences the CO2 automated angiography is usually performed by a 5F pigtail catheter placed at renal arteries level
The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique by a 5F introducer single hole catheter positioned at the distal level of the proximal neck in detecting both renal arteries in the first diagnostic and completion angiographies
Detailed Description:
Endovascular aneurysm repair is currently a wide spread therapeutic option due to a lower 30-day morbiditymortality compared with open repair OR especially in patients with high surgical risk The routinary EVAR technique requires the use of iodinated contrast medium ICM which can cause contrast induced-acute kidney injure CI-AKI The incidence of CI-AKI after EVAR is estimated between 2 and 16 although renal insult can also be caused by microembolization unplanned renal or polar artery coverage renal artery lesion as dissection or post-operative inflammatory reaction
In the past few years several studies pointed out the importance of reducing the amount of iodinated contrast medium injected and proposed carbon dioxide CO2 as an alternative to partially or completely replace ICM especially in patients with preoperative chronic renal impairment
According with the literature manual or automatic CO2 injection provides a good quality imaging of both proximal and distal sealing zone in standard EVAR procedures and combined with fusion imaging allows to perform juxta and pararenal abdominal aortic aneurysm repair with fenestrated endograft reducing the total amount of ICM required to the procedure
The most relevant limit to the use of CO2 is the inability to identify the proximal landing zone and the lowest renal artery that occurs in a significant number of cases 387
This limit could be related to the physical property of CO2 because differently from ICM it is a gas that does not completely fill the aortic lumen but it floats in the anterior portion of the aneurysmatic sac and does not allow the detection of renal arteries with a posterior origin
The automated CO2 injection is commonly performed using a pigtail catheter 5F65mm length placed at the renal arteries level
The primary end point of the study is to identify an alternative and effective method of CO2 injection using an automatic system through the digital Angiodroid injection system Angiodroid Srl San Lazzaro Bologna connected to a 5F introducer placed at the distal portion of infra-renal neck that allows the identification of the lowest renal artery
This is a prospective single center observational case-control study in which each patient is the control of himself because during the procedure 2 angiographic CO2 techniques angiography by pig tail vs 5 F introducer are performed and compared
All patients underwent a preoperative computed tomography angiography CTA within 3 months before the procedure The images are analyzed using a dedicated software for vessel analysis 3Mensio TM Vascular Imaging Bilthover Netherlands and the AAA volume is calculated using the same software by selecting points of the external aortic wall and internal aortic lumen from the lower renal artery to the aortic bifurcation
The level of renal arteries and aortic bifurcation are evaluated on preoperative CTA reconstructions and matched with vertebral bone landmarks
At the beginning of the procedure two CO2 DSA will be performed the first one through the pigtail placed at the level of renal arteries and the second one through a 5F introducer placed at the end of the proximal sealing zone in order to identify the lowest renal artery and compare the quality of the images obtained
The same way at the end of the procedure after the endograft deployment two CO2 DSA will be performed the first one through the pigtail catheter placed at the level of renal arteries and the second one through the 5F introducer placed at the level of the contralateral iliac limb
The investigators prospectively collect clinical and morphological preoperative intraoperative and postoperative data as shown in the table above
Clinical characteristics age years sex hypertension systolic blood pressure 140 orand diastolic 90 mmHg or specific therapy dyslipidemia total cholesterol 200 mgdl or low density lipoprotein 120 mgdl or specific therapy diabetes mellitus pre-diagnosed in therapy with oral hypoglycemic drugs or with insulin current smoking coronary artery disease defined as a history of angina pectoris myocardial infarction or coronary revascularization chronic obstructive pulmonary disease defined as chronic bronchitis or emphysema chronic kidney disease glomerular filtration rate 60 mlmin dialysis pre and post-operative creatinine serum ASA American Society Anesthesiologic classification medical therapy antiplatelet types anticoagulant therapy statin therapy anti-hypertensive medical therapy
Morphological characteristics aneurysm diameter aneurysm volume aneurysm neck features according to Chaickof classification iliac axes features according to Chaickof classification renal arteries number and clock position hypogastric arteries patency aortic carrefour diameter
Intraoperative data anesthesia general or spinal vascular access surgical or percutaneous endograft features bi- or tri-modular suprarenal fixation proximal diameter of the endograft left and right iliac limb diameter embolization of the aneurysmatic sac coils number hypogastric embolization or coverage other adjunctive maneuvers as iliac axes stenting type and amount of contrast medium fluoroscopy time dose area product DAP fluoroscopy DAP DSA DAP and total DAP renal arteries detection at the beginning of the procedure with CO2 DSA from 5F pigtail and 5F introducer renal and hypogastric arteries and endoleaks detection at the end of the procedure with CO2 DSA from 5F pigtail and 5F introducer as explained before
Post-operative data complications related to CO2 injection rate nausea vomit abdominal pain hypotension endoleaks at the discharge perioperative mortality 30-days mortality 30-days medical or surgical complications 30-days reintervention rate 30-days renal function
In the past few years several studies pointed out the importance of reducing the amount of iodinated contrast medium injected and proposed carbon dioxide CO2 as an alternative to partially or completely replace ICM especially in patients with preoperative chronic renal impairment
According with the literature manual or automatic CO2 injection provides a good quality imaging of both proximal and distal sealing zone in standard EVAR procedures and combined with fusion imaging allows to perform juxta and pararenal abdominal aortic aneurysm repair with fenestrated endograft reducing the total amount of ICM required to the procedure
The most relevant limit to the use of CO2 is the inability to identify the proximal landing zone and the lowest renal artery that occurs in a significant number of cases 387
This limit could be related to the physical property of CO2 because differently from ICM it is a gas that does not completely fill the aortic lumen but it floats in the anterior portion of the aneurysmatic sac and does not allow the detection of renal arteries with a posterior origin
The automated CO2 injection is commonly performed using a pigtail catheter 5F65mm length placed at the renal arteries level
The primary end point of the study is to identify an alternative and effective method of CO2 injection using an automatic system through the digital Angiodroid injection system Angiodroid Srl San Lazzaro Bologna connected to a 5F introducer placed at the distal portion of infra-renal neck that allows the identification of the lowest renal artery
This is a prospective single center observational case-control study in which each patient is the control of himself because during the procedure 2 angiographic CO2 techniques angiography by pig tail vs 5 F introducer are performed and compared
All patients underwent a preoperative computed tomography angiography CTA within 3 months before the procedure The images are analyzed using a dedicated software for vessel analysis 3Mensio TM Vascular Imaging Bilthover Netherlands and the AAA volume is calculated using the same software by selecting points of the external aortic wall and internal aortic lumen from the lower renal artery to the aortic bifurcation
The level of renal arteries and aortic bifurcation are evaluated on preoperative CTA reconstructions and matched with vertebral bone landmarks
At the beginning of the procedure two CO2 DSA will be performed the first one through the pigtail placed at the level of renal arteries and the second one through a 5F introducer placed at the end of the proximal sealing zone in order to identify the lowest renal artery and compare the quality of the images obtained
The same way at the end of the procedure after the endograft deployment two CO2 DSA will be performed the first one through the pigtail catheter placed at the level of renal arteries and the second one through the 5F introducer placed at the level of the contralateral iliac limb
The investigators prospectively collect clinical and morphological preoperative intraoperative and postoperative data as shown in the table above
Clinical characteristics age years sex hypertension systolic blood pressure 140 orand diastolic 90 mmHg or specific therapy dyslipidemia total cholesterol 200 mgdl or low density lipoprotein 120 mgdl or specific therapy diabetes mellitus pre-diagnosed in therapy with oral hypoglycemic drugs or with insulin current smoking coronary artery disease defined as a history of angina pectoris myocardial infarction or coronary revascularization chronic obstructive pulmonary disease defined as chronic bronchitis or emphysema chronic kidney disease glomerular filtration rate 60 mlmin dialysis pre and post-operative creatinine serum ASA American Society Anesthesiologic classification medical therapy antiplatelet types anticoagulant therapy statin therapy anti-hypertensive medical therapy
Morphological characteristics aneurysm diameter aneurysm volume aneurysm neck features according to Chaickof classification iliac axes features according to Chaickof classification renal arteries number and clock position hypogastric arteries patency aortic carrefour diameter
Intraoperative data anesthesia general or spinal vascular access surgical or percutaneous endograft features bi- or tri-modular suprarenal fixation proximal diameter of the endograft left and right iliac limb diameter embolization of the aneurysmatic sac coils number hypogastric embolization or coverage other adjunctive maneuvers as iliac axes stenting type and amount of contrast medium fluoroscopy time dose area product DAP fluoroscopy DAP DSA DAP and total DAP renal arteries detection at the beginning of the procedure with CO2 DSA from 5F pigtail and 5F introducer renal and hypogastric arteries and endoleaks detection at the end of the procedure with CO2 DSA from 5F pigtail and 5F introducer as explained before
Post-operative data complications related to CO2 injection rate nausea vomit abdominal pain hypotension endoleaks at the discharge perioperative mortality 30-days mortality 30-days medical or surgical complications 30-days reintervention rate 30-days renal function
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