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Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial

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ClinicalTrials.gov Identifier: NCT00281411
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Clinical Research Office Imaging Division, UMC Utrecht

Brief 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.


Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal 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.

Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up Study of Endovascular Abdominal Aortic Aneurysm Treatment
Study Start Date : March 2001
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Computed Tomography Angiography
    Computed Tomography Angiography
    Procedure: Magnetic Resonance Angiography
    Magnetic Resonance Angiography



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient planned for endovascular abdominal aortic aneurysm repair
Criteria

Inclusion Criteria:

  • Patient is planned for endovascular abdominal aortic aneurysm repair

Exclusion Criteria:

  • contraindication for MRI examination

    • claustrophobia
    • pacemaker
    • other non-MRI compatible implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00281411


Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Clinical Research Office Imaging Division
Investigators
Principal Investigator: W. Mali, MD PhD UMC Utrecht

Responsible Party: Clinical Research Office Imaging Division, Clinical research coordinator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00281411     History of Changes
Other Study ID Numbers: METC.2005.01.291E
First Posted: January 24, 2006    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: November 2016

Keywords provided by Clinical Research Office Imaging Division, 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