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NCT00281411 Clinical Trial

Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial

Aortic Aneurysm, Abdominal Clinical Trial

Official title:
Follow-up Study of Endovascular Abdominal Aortic Aneurysm Treatment

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00281411
Other study ID # METC.2005.01.291E
Secondary ID
Status Completed
Phase N/A
First received January 20, 2006
Last updated February 14, 2018
Start date March 2001
Est. completion date March 2009

Study information
Verified date November 2016
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date March 2009
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patient is planned for endovascular abdominal aortic aneurysm repair

Exclusion Criteria:

- contraindication for MRI examination

- claustrophobia

- pacemaker

- other non-MRI compatible implants

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Computed Tomography Angiography
Computed Tomography Angiography
• Magnetic Resonance Angiography
Magnetic Resonance Angiography

Locations
Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
Clinical Research Office Imaging Division

Country where clinical trial is conducted

Netherlands, 

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