Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by UMC Utrecht.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00281411
First received: January 20, 2006
Last updated: November 17, 2008
Last verified: November 2008
  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

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Estimated Enrollment: 30
Study Start Date: January 2006
Estimated Study Completion Date: January 2009
Intervention Details:
    Procedure: Computed Tomography Angiography
    Computed Tomography Angiography
    Procedure: Magnetic Resonance Angiography
    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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281411

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: W. Mali, MD PhD UMC Utrecht
  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 September 18, 2014