Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial - Full Text View

Sponsored by:	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

MedlinePlus related topics: Aneurysms Aortic Aneurysm CT Scans

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Follow-up Study of Endovascular Abdominal Aortic Aneurysm Treatment

Further study details as provided by UMC Utrecht:

Estimated Enrollment:	30
Study Start Date:	January 2006
Estimated Study Completion Date:	January 2009

Intervention Details:

Computed Tomography 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

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:	UMC Utrecht ( W. Mali )
Study ID Numbers:	METC.2005.01.291E
Study First Received:	January 20, 2006
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00281411 History of Changes
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

Study placed in the following topic categories:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Aortic Aneurysm
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on May 07, 2009