Dynamic CT Imaging After Nellix Endoprosthesis Implantation

June 30, 2016 updated by: Michel Reijnen, Rijnstate Hospital
The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Arnhem, Netherlands, 6815AD
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients eligible for endovascular aortic repair using the Nellix endovascular sealing system

Description

Inclusion Criteria:

  • Nellix implantation

Exclusion Criteria:

  • Use of chimneys or combined with other stent graft material

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group
Patients eligible for AAA repair using Nellix and willing to participate in this trial.
Device: Nellix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Dynamic changes in neck morphology after EVAS
Time Frame: 1 month
1 month
Dynamic changes in common iliac artery morphology after EVAS.
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 6, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StM 596

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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