Endograft Implantation to Repair Abdominal Aortic AneurysmNCT01230684
Contrast Enhanced Ultrasound vs. Computed Tomographic Angiography in the Detection of Endoleaks Following AAA Repair
A study testing Contrast Enhanced Ultrasound (Contrast Agent: OptisonTM) in people with Endograft Implantation to Repair Abdominal Aortic Aneurysm, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of the study is to compare two different types of imaging techniques to identify endoleaks. Following the endovascular procedure, subjects are seen at one month to have computed tomographic angiography (CTA) to confirm the graft is not leaking (endoleak). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endograft Implantation to Repair Abdominal Aortic Aneurysm
- What is being tested?
- Contrast Enhanced Ultrasound (Contrast Agent: OptisonTM)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Nov 2011
- 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
- 18 years old and greater
- Men or postmenopausal/non-pregnant women
- Abdominal aortic aneurysm successfully repaired by endograft deployment
- Creatinine < 2.0 mL
- Planned CTA follow-up
Who cannot join
- Subjects with known or suspected hypersensitivity to blood, blood products, or albumin.
- Subjects unable/unwilling to give informed consent
- Unable to complete post-operative imaging studies
- Subjects identified to have a cardiac shunt by TTE
- Subjects with hepatic or respiratory disease
- Nursing mothers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-5867
About this study
Official title: Comparison of Contrast Enhanced Ultrasound and the Gold Standard Computed Tomographic Angiography in Detection of Endoleak Following Endovascular Abdominal Aortic Aneurysm Repair.
The purpose of the study is to compare two different types of imaging techniques to identify endoleaks. Following the endovascular procedure, subjects are seen at one month to have computed tomographic angiography (CTA) to confirm the graft is not leaking (endoleak). CTA is the standard imaging technique used to identify endoleaks. This study will investigate if the image technique color duplex ultrasound with contrast enhanced ultrasound (CEUS) is a good tool to identify endoleaks too.
Read the detailed description
Background:
Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death. Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs. Despite these more aggressive screening programs and concerted efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to increase.
Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006. Multiple studies reflecting decreased perioperative morbidity and mortality over open repair make this an attractive option for patients. EVAR requires more intensive follow-up than standard open surgical repair, however. Secondary interventions are more common to maintain "seal" of the endograft within the aorta and subsequent exclusion of the aneurysmal component.
The term endoleak is specific to EVAR, and describes the primary means by which endografts fail. Type I endoleaks occur because of inadequate graft seal proximally or distally, resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to collateral flow. Type III endoleaks occur when flow persists between segments of a modular graft. Type IV endoleaks occur when flow persists through endograft material (graft porosity). Type V endoleaks have also been called "endotension", and occur when pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also lead to aneurysm rupture and premature death.
The most common method of EVAR follow-up is computed tomographic angiography (CTA). These studies allow accurate measurement of aneurysm sac diameters and volumes. They also are highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain persistent and are present in the setting of aneurysm sac enlargement. Type I and III endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with current endograft technology.
Study Objectives:
The purpose of the current study is to compare routine postoperative surveillance by CTA with color duplex ultrasound and contrast enhanced ultrasound (CEUS) for the detection of endoleaks.
Study Design
This is a pilot study comparing the imaging techniques of CTA to CEUS in 25 patients undergoing EVAR at their one month post endograft surveillance. The one month standard follow-up will be used for comparing techniques as this will yield the highest number of endoleak positive patients. Patients will complete a color duplex examination in conjunction with CEUS using the FDA approved ultrasound contrast agent OptisonTM (Perflutren Protein Type A Microspheres for Injection, USP). Following ultrasonographic evaluation, study patients will undergo routine CTA.
Eligible subjects will be asked to participate in the trial following post-op day number 1 from their endovascular procedure. Study participation is ~30 days (+ 7 days).
- Being tested
- Contrast Enhanced Ultrasound (Contrast Agent: OptisonTM)
- Keywords
- CEUS, Endoleaks, Abdominal Aortic Aneurysm
- Medical subject headings
- Endoleak, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Ultrasound (Contrast Agent: OptisonTM)Procedure or surgery
The contrast agent will be prepared using a single, 3 mL vial of Optison and 57 mL saline combined in a sterile syringe. Contrast will be set to deliver a continuous infusion at 4 mL/min, via peripheral access. In the event that the above description of the administration of Optison is not adequate for lumen flow contrast enhancement the PI or Co-I will direct the study team to proceed to the secondary administration procedure. This will be done by the following: 0.5 mL of Optison will be injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. The maximum total doses should not exceed 5.0 mL in any 10 minute period nor exceed 8.7 mL in any one patient study. We will follow the insert package dose. We will not not exceed 5.0 or 10 minutes or 8.7ml per patient (this will include the 0.5mL for initial). Therefore, no more that 8.2mL will given in this second administration procedure.
| Study group | Role | What they receive |
|---|---|---|
| Endoleak imaging | Other | In the single arm all participants are recieving both imaging techniques; CEUS and CTA Receives: Procedure: Contrast Enhanced Ultrasound (Contrast Agent: OptisonTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient diagnosed with endoleak via CEUS and confirmed by CTA
Measured: 30 days postoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startDec 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endograft Implantation to Repair Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Eliason, University of Michigan
- Investigators
- Jon Eliason, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230684
- Sponsor's protocol ID
- HUM00038554
- Other IDs
- Internal Grant Award
- Status last verified
- Oct 2017
- First submitted
- 28 Oct 2010
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Contrast Enhanced Ultrasound and the Gold Standard Computed Tomographic Angiography in Detection of Endoleak Following Endovascular Abdominal Aortic Aneurysm Repair.
- ClinicalTrials.gov ID
- NCT01230684
- Acronym / sponsor ID
- HUM00038554
- Keywords
- CEUS, Endoleaks, Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Oct 2010 (estimated)
- 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.
The purpose of the study is to compare two different types of imaging techniques to identify endoleaks. Following the endovascular procedure, subjects are seen at one month to have computed tomographic angiography (CTA) to confirm the graft is not leaking (endoleak). CTA is the standard imaging technique used to identify endoleaks. This study will investigate if the image technique color duplex ultrasound with contrast enhanced ultrasound (CEUS) is a good tool to identify endoleaks too.
Detailed description
Background:
Abdominal aortic aneurysms (AAAs) continue to be a leading cause of death in older age groups. In the 60-85 year-old population, AAA represents the 14th-leading cause of death. Federal funding through Medicare has been allocated for early detection using abdominal ultrasound screening programs. Despite these more aggressive screening programs and concerted efforts by surgeons for timely repair, the incidence of ruptured AAA has continued to increase.
Endovascular aneurysm repair (EVAR) has been the most common type of repair since 2006. Multiple studies reflecting decreased perioperative morbidity and mortality over open repair make this an attractive option for patients. EVAR requires more intensive follow-up than standard open surgical repair, however. Secondary interventions are more common to maintain "seal" of the endograft within the aorta and subsequent exclusion of the aneurysmal component.
The term endoleak is specific to EVAR, and describes the primary means by which endografts fail. Type I endoleaks occur because of inadequate graft seal proximally or distally, resulting in perigraft flow and aneurysm sac pressurization. Type II endoleaks occur when branch arteries arising from the aneurysmal aorta back-bleed into the aneurysm sac due to collateral flow. Type III endoleaks occur when flow persists between segments of a modular graft. Type IV endoleaks occur when flow persists through endograft material (graft porosity). Type V endoleaks have also been called "endotension", and occur when pressurization of the sac occurs in the absence of any demonstrable endoleak. Type I and Type III endoleaks are most concerning for rupture, although persistent Type II endoleaks can also lead to aneurysm rupture and premature death.
The most common method of EVAR follow-up is computed tomographic angiography (CTA). These studies allow accurate measurement of aneurysm sac diameters and volumes. They also are highly sensitive and specific for endoleaks. Type II endoleaks are treated if they remain persistent and are present in the setting of aneurysm sac enlargement. Type I and III endoleaks are immediately treated when identified. Type IV endoleaks are rarely seen with current endograft technology.
Study Objectives:
The purpose of the current study is to compare routine postoperative surveillance by CTA with color duplex ultrasound and contrast enhanced ultrasound (CEUS) for the detection of endoleaks.
Study Design
This is a pilot study comparing the imaging techniques of CTA to CEUS in 25 patients undergoing EVAR at their one month post endograft surveillance. The one month standard follow-up will be used for comparing techniques as this will yield the highest number of endoleak positive patients. Patients will complete a color duplex examination in conjunction with CEUS using the FDA approved ultrasound contrast agent OptisonTM (Perflutren Protein Type A Microspheres for Injection, USP). Following ultrasonographic evaluation, study patients will undergo routine CTA.
Eligible subjects will be asked to participate in the trial following post-op day number 1 from their endovascular procedure. Study participation is ~30 days (+ 7 days).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoleak imaging | Other | Procedure: Contrast Enhanced Ultrasound (Contrast Agent: OptisonTM)In the single arm all participants are recieving both imaging techniques; CEUS and CTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old and greater
- Men or postmenopausal/non-pregnant women
- Abdominal aortic aneurysm successfully repaired by endograft deployment
- Creatinine < 2.0 mL
- Planned CTA follow-up
Key exclusion criteria (6 listed)
- Subjects with known or suspected hypersensitivity to blood, blood products, or albumin.
- Subjects unable/unwilling to give informed consent
- Unable to complete post-operative imaging studies
- Subjects identified to have a cardiac shunt by TTE
- Subjects with hepatic or respiratory disease
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 Enhanced Ultrasound (Contrast Agent: OptisonTM)The contrast agent will be prepared using a single, 3 mL vial of Optison and 57 mL saline combined in a sterile syringe. Contrast will be set to deliver a continuous infusion at 4 mL/min, via peripheral access. In the event that the above description of the administration of Optison is not adequate for lumen flow contrast enhancement the PI or Co-I will direct the study team to proceed to the secondary administration procedure. This will be done by the following: 0.5 mL of Optison will be injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. The maximum total doses should not exceed 5.0 mL in any 10 minute period nor exceed 8.7 mL in any one patient study. We will follow the insert package dose. We will not not exceed 5.0 or 10 minutes or 8.7ml per patient (this will include the 0.5mL for initial). Therefore, no more that 8.2mL will given in this second administration procedure. | Procedure or surgery | Endoleak imaging |
Primary outcome
Patient diagnosed with endoleak via CEUS and confirmed by CTA
Time frame: 30 days postoperative visit
Results and safety
The study was stopped early (reason given: Due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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.
Jon Eliason, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Enhanced Ultrasound (Contrast Agent: OptisonTM) in people with Endograft Implantation to Repair Abdominal Aortic Aneurysm, run by University of Michigan at 1 site in United States.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Due to low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient diagnosed with endoleak via CEUS and confirmed by CTA (time frame: 30 days postoperative visit). 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 26 Oct 2017.