NCT00680004

Brief Summary

This pilot study aims to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in patients scheduled for standard endograft follow-up. The developed techniques will be applied in future studies for characterizing and comparing the currently commercially available endografts so as to gain insight into the mechanisms underlying potential endograft failure. In addition, to assist in developing endografts with long-term durability and functioning characteristics for the benefit of the patient

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 19, 2008

Status Verified

May 1, 2008

Enrollment Period

1.7 years

First QC Date

May 15, 2008

Last Update Submit

May 16, 2008

Conditions

Keywords

Dynamic CTAfollow-upEVAR

Outcome Measures

Primary Outcomes (1)

  • to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in terms of longitudinal movement

Secondary Outcomes (1)

  • evaluate the integrity of the endograft by visualization using CT in the longitudinal and transversal plane at several moments during the cardiac cycle versus the standard transverse plane method

Study Arms (2)

1

Preoperative patients planned for a CT prior to an endograft implantation procedure

2

Patients who underwent a complicated endograft implant and/or with increased risk of complications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing either a preoperative CT procedure or with an implanted aortic endoprothesis (-graft) presenting to the department of radiology for a scheduled follow-up CTA procedure.

You may qualify if:

  • Preoperative patients planned for a CT prior to an endograft implantation procedure
  • Patients who underwent a complicated endograft implant and/or with increased risk of complications
  • years of age or older
  • Patients who have given their informed consent

You may not qualify if:

  • Known allergy for contrast medium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC St Radboud

Nijmegen, 6525GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Leo Schultze Kool, MD

    UMC St Radboud Nijmegen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leo Schultze Kool, MD

CONTACT

Jan Blankensteijn, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2008

First Posted

May 19, 2008

Study Start

January 1, 2007

Primary Completion

September 1, 2008

Study Completion

December 1, 2009

Last Updated

May 19, 2008

Record last verified: 2008-05

Locations