NCT00281411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 15, 2018

Status Verified

November 1, 2016

First QC Date

January 20, 2006

Last Update Submit

February 14, 2018

Conditions

Aortic Aneurysm, Abdominal

Keywords

Blood Vessel Prosthesis ImplantationEndovascular aneurysm repairMagnetic Resonance AngiographyComputed Tomography AngiographyEndoleak

Interventions

Computed Tomography AngiographyPROCEDURE

Computed Tomography Angiography

Magnetic Resonance AngiographyPROCEDURE

Magnetic Resonance Angiography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient planned for endovascular abdominal aortic aneurysm repair

You may qualify if:

  • Patient is planned for endovascular abdominal aortic aneurysm repair

You may not qualify if:

  • contraindication for MRI examination
  • claustrophobia
  • pacemaker
  • other non-MRI compatible implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalEndoleak

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesPostoperative HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • W. Mali, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical research coordinator

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 24, 2006

Study Start

March 1, 2001

Study Completion

March 1, 2009

Last Updated

February 15, 2018

Record last verified: 2016-11

Locations

NL(1)