Abdominal Aortic AneurysmNCT00483665
Vasovist Endoleak Study
An observational study of Abdominal Aortic Aneurysm, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is needed to monitor the effectiveness of the treatment. One parameter in this follow-up is endoleak, which is leakage of blood into the aneurysm sac. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Computed tomography angiography and Magnetic resonance imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2006to not given
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients after more than 1 year who have a stable or growing aneurysm according to diameters measured on CT angiography images and no evidence of endoleak on recent CT angiography
Who may be able to join
- Patient is more than one year after endovascular abdominal aortic aneurysm repair
- Patient has a stable or growing aneurysm according to diameters measured on CT angiography images
- No evidence of endoleak on recent CT angiography
Who cannot join
- contraindication for MRI examination
- claustrophobia
- pacemaker
- other non-MRI compatible implants
- contraindication for use of contrast agent
- known allergy to drugs or contrast media
Show all 10Show fewer
- MRI examination with the use of gadolinium within 24 hours of the blood-pool agent injection
- severe renal impairment = creatine > 2 mg/dl (=176 mmol/l)
- patient clinically instable
- Participation in drug research within 30 days before and 1 day after MRI-examination with use of Vasovist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging
After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is needed to monitor the effectiveness of the treatment. One parameter in this follow-up is endoleak, which is leakage of blood into the aneurysm sac. The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.
Read the detailed description
After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm diameter and the presence of endoleaks is evaluated with computed tomographic (CT) angiography yearly after Endovascular Aneurysm Repair (EVAR).
The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.
The advantages of magnetic resonance imaging with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Computed tomography angiography, Magnetic resonance imaging
- Keywords
- endoleak
- 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.
Computed tomography angiographyProcedure or surgery
Computed tomography angiography
Magnetic resonance imagingProcedure or surgery
Magnetic resonance imaging after injection of Vasovist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startJun 2006
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Investigators
- Mathias Prokop, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483665
- Sponsor's protocol ID
- UMC_06_112
- Status last verified
- Nov 2008
- First submitted
- 6 Jun 2007
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Endoleak by Vasovist-Enhanced Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00483665
- Acronym / sponsor ID
- UMC_06_112
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- endoleak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Jun 2006
- First posted
- 7 Jun 2007 (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.
After endovascular treatment of an abdominal aortic aneurysm, lifelong imaging follow-up is needed to monitor the effectiveness of the treatment. One parameter in this follow-up is endoleak, which is leakage of blood into the aneurysm sac. The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.
Detailed description
After endovascular abdominal aortic aneurysm repair, life-long follow-up is needed to monitor the effectiveness of exclusion of the aneurysm sac from blood flow. For this reason, aneurysm diameter and the presence of endoleaks is evaluated with computed tomographic (CT) angiography yearly after Endovascular Aneurysm Repair (EVAR).
The aim of this study is to investigate the value of magnetic resonance imaging using Vasovist as a contrast agent for the detection of endoleaks.
The advantages of magnetic resonance imaging with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients after more than 1 year who have a stable or growing aneurysm according to diameters measured on CT angiography images and no evidence of endoleak on recent CT angiography
Key inclusion criteria (3 listed)
- Patient is more than one year after endovascular abdominal aortic aneurysm repair
- Patient has a stable or growing aneurysm according to diameters measured on CT angiography images
- No evidence of endoleak on recent CT angiography
Key exclusion criteria (10 listed)
- contraindication for MRI examination
- contraindication for use of contrast agent
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 |
|---|---|---|
| Computed tomography angiographyComputed tomography angiography | Procedure or surgery | – |
| Magnetic resonance imagingMagnetic resonance imaging after injection of Vasovist | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
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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.
Mathias Prokop, MD PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by UMC Utrecht at 1 site in Netherlands.
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 10 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: finished, as of the sponsor's last update on 19 Nov 2008. 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 19 Nov 2008; AzTrials last refreshed its copy on 27 Oct 2026.