Abdominal Aortic AneurysmNCT04089241
Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair
A study testing Contrast 3D Ultrasound in people with Abdominal Aortic Aneurysm and Endoleak, run by Rambam Health Care Campus.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Endoleak
- What is being tested?
- Contrast 3D Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of AAA
- AAA treated endovascularly
- Patients send from the outpatient clinic to a follow up imaging study
Who cannot join
- AAA treated surgically and not endovascularly
Trial locations and contacts
No sites are listed yet.
NIra Beck-Razi, MD contact
About this study
Official title: Fusion of CT Angiography (CTA ) With 3D Contrast Enhanced Ultrasound ( CEUS ) as a Method for Follow up After Endovascular Aneurysm Repair (EVR)
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 stentgraft.Today, 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 high.In 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 Gadolinium.A 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
Read the detailed description
Abdominal Aortic Aneurysm (AAA) is a known vascular entity that may be life threatening and requires treatment once it's diameter exceeds 5.5 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 literature3,4.
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
- Conditions
- Abdominal Aortic Aneurysm, Endoleak
- Being tested
- Contrast 3D Ultrasound
- Medical subject headings
- Aortic Aneurysm, Abdominal, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast 3D UltrasoundOther
an ultrasound examination which will include a 3D reconstruction and thereafter CEUS will be performed using SONOVIEW contrast agent
| Study group | Role | What they receive |
|---|---|---|
| all cohort | Experimental | Patients will perform CTA 1 months after the EVAR procedure. Following CTA, an ultrasound examination which will include a 3D reconstruction and CEUS will be performed using SONOVIEW contrast agent. The dimensions and volume of the aorta will be compared to the measurements in CTA using the fusion method. In the case of endoleak type 1 or 3 the patient will be urgently refered to endovascular repair . In the case of endoleak type 2 or a normal exam the patient will undergo another fused exam with CEUS at 6 month . In the case of endoleak type 2 with a growth of more than 1 cm in the aneurysm diameter , the patient will be refered to endovascular repair. In the case of a normal exam or an endoleak type 2 with a shrinkage of 1 cm or more ,the patient will undergo another fused exam with CEUS at 12 months. At any case of a new endoleak type 1 or 3 the patient will undergo CTA. Receives: Other: Contrast 3D Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the detection of endoleak by contrast 3D Ultrasound fused with CTA in the follow up of EVAR patients
For each patient that will undergo the fused modality , the results of the presence or absence of endoleak and the type of the endoleak, if detected, will be compared to the gold standard CTA .
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study startSep 2020 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erez Klein, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089241
- Sponsor's protocol ID
- 490-19RMB
- Status last verified
- Sep 2020
- First submitted
- 29 Aug 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusion of CT Angiography (CTA ) With 3D Contrast Enhanced Ultrasound ( CEUS ) as a Method for Follow up After Endovascular Aneurysm Repair (EVR)
- ClinicalTrials.gov ID
- NCT04089241
- Acronym / sponsor ID
- 490-19RMB
- Conditions
- Abdominal Aortic Aneurysm, Endoleak
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 stentgraft.Today, 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 high.In 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 Gadolinium.A 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 it's diameter exceeds 5.5 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 literature3,4.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all cohort | Experimental | Other: Contrast 3D UltrasoundPatients will perform CTA 1 months after the EVAR procedure. Following CTA, an ultrasound examination which will include a 3D reconstruction and CEUS will be performed using SONOVIEW contrast agent. The dimensions and volume of the aorta will be compared to the measurements in CTA using the fusion method. In the case of endoleak type 1 or 3 the patient will be urgently refered to endovascular repair . In the case of endoleak type 2 or a normal exam the patient will undergo another fused exam with CEUS at 6 month . In the case of endoleak type 2 with a growth of more than 1 cm in the aneurysm diameter , the patient will be refered to endovascular repair. In the case of a normal exam or an endoleak type 2 with a shrinkage of 1 cm or more ,the patient will undergo another fused exam with CEUS at 12 months. At any case of a new endoleak type 1 or 3 the patient will undergo CTA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of AAA
- AAA treated endovascularly
- Patients send from the outpatient clinic to a follow up imaging study
Key exclusion criteria (1 listed)
- AAA treated surgically and not endovascularly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast 3D Ultrasoundan ultrasound examination which will include a 3D reconstruction and thereafter CEUS will be performed using SONOVIEW contrast agent | Other | all cohort |
Primary outcome
Accuracy of the detection of endoleak by contrast 3D Ultrasound fused with CTA in the follow up of EVAR patients
Time frame: two years
For each patient that will undergo the fused modality , the results of the presence or absence of endoleak and the type of the endoleak, if detected, will be compared to the gold standard CTA .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NIra Beck-Razi, MD contact
Erez Klein, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing Contrast 3D Ultrasound in people with Abdominal Aortic Aneurysm and Endoleak, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erez Klein, MD (97247772664, erezklein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the detection of endoleak by contrast 3D Ultrasound fused with CTA in the follow up of EVAR patients (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.