NCT02349100

Brief Summary

To determine FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis. Does uncomplicated EVAR using the nellix endoprosthesis result in increased FDG uptake and false positive PET imaging?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

January 12, 2015

Last Update Submit

April 10, 2017

Conditions

Aortic AneurysmEndovascular Repair

Outcome Measures

Primary Outcomes (1)

  • Difference in physiological FDG uptake following Nellix EVAS implantation in patients without known infections or malignancies as measured by standard uptake values (SUV)

    Comparing pre- and post-implantation FDG uptake with ROI set at the aneurysm and stent. Measured SUV from FDG emission will be compared and subtracted and the difference will be reported (in MBq/kg).

    1 month

Study Arms (1)

Treated group

Patient group treated with Nellix Endoprosthesis.

Device: Nellix Endoprosthesis

Interventions

Nellix EndoprosthesisDEVICE

Implantation of Nellix

Treated group

Eligibility Criteria

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

Patients with abdominal aortic aneurysms eligible for EVAS with Nellix endoprosthesis.

You may qualify if:

  • Patients treated with Nellix endoprosthesis

You may not qualify if:

  • Diabetes Mellitus (Type 1 and type 2)
  • Current known inflammation or malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Ziekenhuis

Arnhem, Gelderland, 6815AD, Netherlands

Location

Related Publications (1)

  • Groot Jebbink E, van Den Ham LH, van Woudenberg BBJ, Slart RHJA, Zeebregts CJ, Rijnders TJM, Lardenoije JHP, Reijnen MMPJ. Physiological Appearance of Hybrid FDG-Positron Emission Tomography/Computed Tomography Imaging Following Uncomplicated Endovascular Aneurysm Sealing Using the Nellix Endoprosthesis. J Endovasc Ther. 2020 Jun;27(3):509-515. doi: 10.1177/1526602820913888. Epub 2020 Apr 15.

    PMID: 32295455DERIVED

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Michel Reijnen, PhD, MD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD.

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 28, 2015

Study Start

January 1, 2015

Primary Completion

July 13, 2016

Study Completion

August 30, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

NL(1)