Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial

NCT ID: NCT00281411

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aortic Aneurysm, Abdominal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Computed Tomography Angiography

Computed Tomography Angiography

Intervention Type PROCEDURE

Magnetic Resonance Angiography

Magnetic Resonance Angiography

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient is planned for endovascular abdominal aortic aneurysm repair

Exclusion Criteria

* contraindication for MRI examination

* claustrophobia
* pacemaker
* other non-MRI compatible implants
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Research Office Imaging Division

OTHER

Sponsor Role lead

Responsible Party

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Clinical Research Office Imaging Division

Clinical research coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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W. Mali, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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METC.2005.01.291E

Identifier Type: -

Identifier Source: org_study_id

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