| Sponsor: | UMC Utrecht |
|---|---|
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00281411 |
Purpose
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.
| Condition | Intervention |
|---|---|
| Aortic Aneurysm, Abdominal |
Procedure: Computed Tomography Angiography Procedure: Magnetic Resonance Angiography |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Follow-up Study of Endovascular Abdominal Aortic Aneurysm Treatment |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | January 2009 |
-
Procedure: Computed Tomography Angiography
Procedure: Magnetic Resonance Angiography
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patient planned for endovascular abdominal aortic aneurysm repair
Inclusion Criteria:
- Patient is planned for endovascular abdominal aortic aneurysm repair
Exclusion Criteria:
-
contraindication for MRI examination
- claustrophobia
- pacemaker
- other non-MRI compatible implants
Contacts and Locations
More Information
No publications provided
| Responsible Party: | W. Mali, UMC Utrecht |
| ClinicalTrials.gov Identifier: |
NCT00281411 History of Changes |
| Other Study ID Numbers: | METC.2005.01.291E |
| Study First Received: | January 20, 2006 |
| Last Updated: | November 17, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by UMC Utrecht:
|
Blood Vessel Prosthesis Implantation Endovascular aneurysm repair Magnetic Resonance Angiography Computed Tomography Angiography Endoleak |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on August 21, 2012
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