Aortic Aneurysm, AbdominalNCT00281411
Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial
An observational study of Aortic Aneurysm, Abdominal, run by Clinical Research Office Imaging Division at 1 site in Netherlands.
Trial summary
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 CT angiography yearly after Endovascular Aneurysm Repair (EVAR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Computed Tomography Angiography and Magnetic Resonance Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2001to Mar 2009
- 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: Patient planned for endovascular abdominal aortic aneurysm repair
Who may be able to join
- Patient is planned for endovascular abdominal aortic aneurysm repair
Who cannot join
- contraindication for MRI examination
- claustrophobia
- pacemaker
- other non-MRI compatible implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up Study of Endovascular Abdominal Aortic Aneurysm Treatment
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 CT angiography yearly after Endovascular Aneurysm Repair (EVAR).
The aim of this study is to investigate the value of MRA examinations for the follow-up of these patients. The advantages of MRA with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.
Read the detailed description
The FEAT trial (Follow-up of Endovascular Aneurysm Treatment) is designed as a prospective, single-center, follow-up study. 100 Patients will be enrolled in this study. These patients will undergo additional MRA-examinations the day before EVAR, the day after EVAR, 6 months and 1 year after EVAR. These patients also participate in the conventional CTA follow-up scheme which comprises a pre- and post-operative CTA and a CTA yearly thereafter. Coagulation parameters in the blood will be measured before and 1 year after EVAR.
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Computed Tomography Angiography, Magnetic Resonance Angiography
- Keywords
- Blood Vessel Prosthesis Implantation, Endovascular aneurysm repair, Magnetic Resonance Angiography, Computed Tomography Angiography, 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 AngiographyProcedure or surgery
Magnetic Resonance Angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study startMar 2001
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Office Imaging Division
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Clinical Research Office Imaging Division, UMC Utrecht
- Investigators
- W. Mali, MD PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281411
- Sponsor's protocol ID
- METC.2005.01.291E
- Status last verified
- Nov 2016
- First submitted
- 20 Jan 2006
- Last updated
- 15 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of Endovascular Abdominal Aortic Aneurysm Treatment
- ClinicalTrials.gov ID
- NCT00281411
- Acronym / sponsor ID
- METC.2005.01.291E
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- Blood Vessel Prosthesis Implantation, Endovascular aneurysm repair, Magnetic Resonance Angiography, Computed Tomography Angiography, Endoleak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Clinical Research Office Imaging DivisionUniversity, hospital or other
- Study start
- Mar 2001
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Jan 2006 (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 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 CT angiography yearly after Endovascular Aneurysm Repair (EVAR).
The aim of this study is to investigate the value of MRA examinations for the follow-up of these patients. The advantages of MRA with respect to CTA are no use of ionizing radiation, use of less nephrotoxic contrast agents.
Detailed description
The FEAT trial (Follow-up of Endovascular Aneurysm Treatment) is designed as a prospective, single-center, follow-up study. 100 Patients will be enrolled in this study. These patients will undergo additional MRA-examinations the day before EVAR, the day after EVAR, 6 months and 1 year after EVAR. These patients also participate in the conventional CTA follow-up scheme which comprises a pre- and post-operative CTA and a CTA yearly thereafter. Coagulation parameters in the blood will be measured before and 1 year after EVAR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient planned for endovascular abdominal aortic aneurysm repair
Key inclusion criteria (1 listed)
- Patient is planned for endovascular abdominal aortic aneurysm repair
Key exclusion criteria (4 listed)
- contraindication for MRI examination
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 AngiographyMagnetic Resonance Angiography | 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 15 Feb 2018.
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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.
W. Mali, 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 Aortic Aneurysm, Abdominal, run by Clinical Research Office Imaging Division 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 1 inclusion and 4 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 15 Feb 2018. 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 15 Feb 2018.