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Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089241
Recruitment Status : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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 stentgraft.Today, accepted EVAR follow up protocol consists of a multiple multiphasic CT angiography (CTA) scan . Hazards of these follow up CTA exams include repetitive radiation exposure, nephrotoxicity and allergic reactions. 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 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 the manner of radiation exposure and possible contrast media related adverse reaction reduction, thus allowing this method to become the possible gold standard exam for follow up EVAR patients.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Endoleak Other: Contrast 3D Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fusion of CT Angiography (CTA ) With 3D Contrast Enhanced Ultrasound ( CEUS ) as a Method for Follow up After Endovascular Aneurysm Repair (EVR)
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Ultrasound

Arm Intervention/treatment
Experimental: all cohort
Patients will perform CTA 3 months after the EVAR procedure. Following CTA, an ultrasound examination which will include a 3D reconstruction and thereafter 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. The same protocol will be then performed 6 and 12 months post intervention.
Other: Contrast 3D Ultrasound
an ultrasound examination which will include a 3D reconstruction and thereafter CEUS will be performed using SONOVIEW contrast agent




Primary Outcome Measures :
  1. 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 .



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients with a diagnosis of AAA
  • AAA treated endovascularly
  • Patients send from the outpatient clinic to a follow up imaging study

Exclusion Criteria

• AAA treated surgically and not endovascularly


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089241


Contacts
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Contact: Erez Klein, MD 97247772664 erezklein@gmail.com
Contact: NIra Beck-Razi, MD n_beck_razi@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Erez Klein, MD Rambam Health Care Campus

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT04089241    
Other Study ID Numbers: 490-19RMB
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Endoleak
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Postoperative Hemorrhage
Hemorrhage
Pathologic Processes
Postoperative Complications