Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04089241
Status:
UNKNOWN
Last Update Posted:
2020-09-09
First Post:
2019-08-29
Brief Title:
Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Fusion of CT Angiography CTA With 3D Contrast Enhanced Ultrasound CEUS as a Method for Follow up After Endovascular Aneurysm Repair EVR
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_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:
Abdominal Aortic Aneurysm AAA is a known vascular entity that may be life threatening condition The most common treatment approach nowadays is the endovascular approach a procedure known as endovascular aortic repair EVAR The most common procedure related complication is the expansion of the aneurysm from a feeding vessel usually a lumbar or intercostal artery Another known complication is an endoleak from the stentgraftToday accepted EVAR follow up protocol consists of one multiple multiphasic CT angiography CTA scan one month after the procedure and ultrasound exams there after Ultrasonography is a useful method for detection and evaluation of AAA has no ionizing radiation and is useful for the dynamic estimation of the aortic width in patients post EVAR However the sensitivity of ultrasonography solely for detection of endoleaks in post EVAR patients is not highIn recent years the development of fusion applications allows the dual modality merge between ultrasound and CT scans that can be used as follow up examinations of known imaging findings on CT Another application that had been developed for ultrasound machines is the ability to generate a 3 dimensional 3D reconstruction which allows more precision In the recent year the usage of intravenous contrast agent for ultrasonography based on microbubbles BRACO SONOVIEW has been approved by the Israeli ministry of health This contrast agent is not nephrotoxic and the risk for allergic reaction is very low statistically similar to GadoliniumA 3D contrast enhanced ultrasonography fused together with CTA may be a helpfull addition which lacks radiation and odine contrast reactions and nephrotoxicity in the follow up in post EVAR patients by means of identifing endoleaks at an earlier stage than by ultrasound alone The purpose of our research is to evaluate the combined modality fusion of CTA with CEUS mentioned above in identifing early endoleaks in post EVAR patients and thus enabilng early intervention when needed
Detailed Description:
Abdominal Aortic Aneurysm AAA is a known vascular entity that may be life threatening and requires treatment once its diameter exceeds 55 cm or in any diameter in symptomatic patients
Known risk factors for developing Abdominal Aortic Aneurysm AAA include tabacco consumption Sex male predominance age above 65 with a history of smoking or age above 75 without a history of smoking hypertension diabetes mellitus and hyperchlesterolemia1 The most common treatment approach nowadays is the endovascular approach a procedure known as endovascular aortic repair EVAR The most common procedure related complication is the expansion of the aneurysm from a feeding vessel usually a lumbar or intercostal artery Another known complication is an endoleak from the stentgraft through its proximal or distal part
Today accepted EVAR follow up protocol consists of a multiphasic CT angiography CTA scan The initial scan is performed without contrast the second scan is performed in the arterial phase and a third scan is performed in the late portal phase CTA is performed at one month after the procedure and ultrasound exams there after
Ultrasonography is a useful method for detection and evaluation of AAA and is recommended as an annual screening tool for patients above 65 with smoking history or above 75 without smoking history Duplex Ultrasonography has no ionizing radiation and is useful for the dynamic estimation of the aortic width in patients post EVAR However the sensitivity of ultrasonography solely for detection of endoleaks in post EVAR patients is not high mostly due to known inborn limitations of ultrasound including decreased penetration in obese patients and suboptimal demonstration of retroperitoneal structures due to gas in the intestine
In recent years the development of fusion applications allow the dual modality merge between ultrasound and CT scans The dual modality allows the direct comparison of imaging findings in real time Fusion imaging is used as follow up examinations of known imaging findings on CT that cannot be optimally demonstrated on ultrasonography Once these findings are followed up by ultrasonography an substantial amount of radiation can be reduced
Another application that had been developed for ultrasound machines nowadays is the ability to generate a 3 dimensional 3D reconstruction which allows more precision 2D and 3D ultrasound imaging as a follow up imaging modality after endovascular aortic repair EVAR procedures has been described in medical literature34
In the recent year the usage of intravenous contrast agent for ultrasonography based on microbubbles BRACO SONOVIEW has been approved by the Israeli ministry of health This intravenous contrast agent has been in usage for several years in Europe and have been recently approved officially in our country in the examination of liver breast vascular cerebral lesions and peripheral blood vessels This contrast agent is not nephrotoxic and the risk for allergic reaction is very low statistically similar to Gadolinium The contrast agent is purely intravascular and does not leak to the the interstitium therefore can be used efficiently for the detection of endoleaks
This contrast agent has yet to be approved by ministry of health for the application in aorta imaging Nevertheless the European federation of societies for ultrasound in medicine and biology EFSUMB has specific guidelines for the usage of this contrast agent for the detection of stent grafts endoleaks 5
A 3D contrast enhanced ultrasonography fused together with CTA may be an appropriate substitute for the standard CTA follow up in post EVAR patients and thus substantially reduce radiation doses as well as iodine contrast reactions and nephrotoxicity
The purpose of our research is to evaluate the combined modality fusion of CTA with CEUS mentioned above in identifing early endoleaks in post EVAR patients and thus enabilng early intervention when needed
Known risk factors for developing Abdominal Aortic Aneurysm AAA include tabacco consumption Sex male predominance age above 65 with a history of smoking or age above 75 without a history of smoking hypertension diabetes mellitus and hyperchlesterolemia1 The most common treatment approach nowadays is the endovascular approach a procedure known as endovascular aortic repair EVAR The most common procedure related complication is the expansion of the aneurysm from a feeding vessel usually a lumbar or intercostal artery Another known complication is an endoleak from the stentgraft through its proximal or distal part
Today accepted EVAR follow up protocol consists of a multiphasic CT angiography CTA scan The initial scan is performed without contrast the second scan is performed in the arterial phase and a third scan is performed in the late portal phase CTA is performed at one month after the procedure and ultrasound exams there after
Ultrasonography is a useful method for detection and evaluation of AAA and is recommended as an annual screening tool for patients above 65 with smoking history or above 75 without smoking history Duplex Ultrasonography has no ionizing radiation and is useful for the dynamic estimation of the aortic width in patients post EVAR However the sensitivity of ultrasonography solely for detection of endoleaks in post EVAR patients is not high mostly due to known inborn limitations of ultrasound including decreased penetration in obese patients and suboptimal demonstration of retroperitoneal structures due to gas in the intestine
In recent years the development of fusion applications allow the dual modality merge between ultrasound and CT scans The dual modality allows the direct comparison of imaging findings in real time Fusion imaging is used as follow up examinations of known imaging findings on CT that cannot be optimally demonstrated on ultrasonography Once these findings are followed up by ultrasonography an substantial amount of radiation can be reduced
Another application that had been developed for ultrasound machines nowadays is the ability to generate a 3 dimensional 3D reconstruction which allows more precision 2D and 3D ultrasound imaging as a follow up imaging modality after endovascular aortic repair EVAR procedures has been described in medical literature34
In the recent year the usage of intravenous contrast agent for ultrasonography based on microbubbles BRACO SONOVIEW has been approved by the Israeli ministry of health This intravenous contrast agent has been in usage for several years in Europe and have been recently approved officially in our country in the examination of liver breast vascular cerebral lesions and peripheral blood vessels This contrast agent is not nephrotoxic and the risk for allergic reaction is very low statistically similar to Gadolinium The contrast agent is purely intravascular and does not leak to the the interstitium therefore can be used efficiently for the detection of endoleaks
This contrast agent has yet to be approved by ministry of health for the application in aorta imaging Nevertheless the European federation of societies for ultrasound in medicine and biology EFSUMB has specific guidelines for the usage of this contrast agent for the detection of stent grafts endoleaks 5
A 3D contrast enhanced ultrasonography fused together with CTA may be an appropriate substitute for the standard CTA follow up in post EVAR patients and thus substantially reduce radiation doses as well as iodine contrast reactions and nephrotoxicity
The purpose of our research is to evaluate the combined modality fusion of CTA with CEUS mentioned above in identifing early endoleaks in post EVAR patients and thus enabilng early intervention when needed
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