Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337890
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-18
Brief Title:
CO2 Automated Angiographies With Fusion Imaging for Zero- or Near Zero- Contrast FEVAR
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
The Use of CO2 Automated Angiographies Combined With Fusion Imaging to Obtain Zero- or Near Zero- Contrast FEVAR for Complex Aortic Aneurysms
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Fenestrated endovascular aneurysm repair FEVAR is an established technique used to treat complex aortic aneurysms TAAAs with satisfactory early and midterm results
Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay higher morbidity and long-term mortality in the peri-operative period and during follow-up One of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium ICM
Automated carbon dioxide CO2 angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair EVAR in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function
In adjunct hybrid room and fusion imaging FI technologies are useful tools to reduce intraoperative contrast medium and fluoroscopy time
In literature there are few reports regarding the use of CO2 for fenestrated endografting repair of complex aortic aneurysms
The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms
Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay higher morbidity and long-term mortality in the peri-operative period and during follow-up One of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium ICM
Automated carbon dioxide CO2 angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair EVAR in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function
In adjunct hybrid room and fusion imaging FI technologies are useful tools to reduce intraoperative contrast medium and fluoroscopy time
In literature there are few reports regarding the use of CO2 for fenestrated endografting repair of complex aortic aneurysms
The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms
Detailed Description:
Fenestrated endovascular aneurysm repair FEVAR is an established technique used to treat juxtarenal and pararenal abdominal aortic aneurysms AAAs and type IV thoracoabdominal aortic aneurysms TAAAs as demonstrated by early and midterm literature results
Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay higher morbidity and long-term mortality in the peri-operative period and during follow-up
Renal function may worsen after FEVAR because of a variety of factors but one of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium ICM
Automated CO2 angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair EVAR in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function
In adjunct hybrid room and fusion imaging FI technologies based on a three-dimensional preoperative computed tomography angiography CTA image over-laid on a two-dimensional live fluoroscopy image are useful tools to reduce intraoperative contrast medium and fluoroscopy time
The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms
ENDPOINTS
Early - Technical success defined as correct endograft deployment with stenting and patency of all planned target visceral vessels TVVs and absence of type I and type III endoleaks iliac leg stenosis or kinking and mortality at 24 hours
in-hospital30-day reintervention and mortality
perioperative renal function worsening according to the RIFLE Risk Injury Failure Loss of kidney function End-stage renal disease criteria
Follow-up - Freedom from TVVs instability
Survival
Freedom from reintervention
Freedom from renal function worsening
CO2 Injection protocol
Diagnostic CO2 angiographies are performed in the anteroposterior and 90-degree lateral projections from a 6F sheet positioned in the pararenal aorta by an automated CO2 injector Angiodroid San Lazzaro Bologna Italy
The FIVesselNavigator is optimized with these two CO2 angiography images and the TVV origins The injection pressure and volume are usually set at 650 mmHg and 100 ml respectively Carbon dioxide angiographies are repeated step by step after endograft introduction and during endograft deployment to adjust the endografts position according to fusion images
To evaluate cannulation and bridging stentgraft deployment in each TVVs CO2 angiographies are performed with the 6F sheet for superior mesenteric artery and for the other TVVs with selective angiographies through the TVVs sheet
In this case the injection pressure is set at 300 mmHg while the injection volume is set at 40 mL
The angiographic shots required to deploy the bifurcated graft and the contralateral iliac leg are usually performed through an automated CO2 injection from the femoral sheaths
Completion angiography is performed through 6F sheet positioned in the proximal portion of the endograft in both anteroposterior and lateral views
FOLLOW-UP
30-day CTA scan blood tests 3 months duplex ultrasound DUS or CTA scan in case of any doubt blood tests 6 months DUS blood tests 12 months CTA scan blood tests
During the follow-up clinical evaluations will be performed as per standard clinical practice for patients with this condition
Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay higher morbidity and long-term mortality in the peri-operative period and during follow-up
Renal function may worsen after FEVAR because of a variety of factors but one of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium ICM
Automated CO2 angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair EVAR in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function
In adjunct hybrid room and fusion imaging FI technologies based on a three-dimensional preoperative computed tomography angiography CTA image over-laid on a two-dimensional live fluoroscopy image are useful tools to reduce intraoperative contrast medium and fluoroscopy time
The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms
ENDPOINTS
Early - Technical success defined as correct endograft deployment with stenting and patency of all planned target visceral vessels TVVs and absence of type I and type III endoleaks iliac leg stenosis or kinking and mortality at 24 hours
in-hospital30-day reintervention and mortality
perioperative renal function worsening according to the RIFLE Risk Injury Failure Loss of kidney function End-stage renal disease criteria
Follow-up - Freedom from TVVs instability
Survival
Freedom from reintervention
Freedom from renal function worsening
CO2 Injection protocol
Diagnostic CO2 angiographies are performed in the anteroposterior and 90-degree lateral projections from a 6F sheet positioned in the pararenal aorta by an automated CO2 injector Angiodroid San Lazzaro Bologna Italy
The FIVesselNavigator is optimized with these two CO2 angiography images and the TVV origins The injection pressure and volume are usually set at 650 mmHg and 100 ml respectively Carbon dioxide angiographies are repeated step by step after endograft introduction and during endograft deployment to adjust the endografts position according to fusion images
To evaluate cannulation and bridging stentgraft deployment in each TVVs CO2 angiographies are performed with the 6F sheet for superior mesenteric artery and for the other TVVs with selective angiographies through the TVVs sheet
In this case the injection pressure is set at 300 mmHg while the injection volume is set at 40 mL
The angiographic shots required to deploy the bifurcated graft and the contralateral iliac leg are usually performed through an automated CO2 injection from the femoral sheaths
Completion angiography is performed through 6F sheet positioned in the proximal portion of the endograft in both anteroposterior and lateral views
FOLLOW-UP
30-day CTA scan blood tests 3 months duplex ultrasound DUS or CTA scan in case of any doubt blood tests 6 months DUS blood tests 12 months CTA scan blood tests
During the follow-up clinical evaluations will be performed as per standard clinical practice for patients with this condition
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