NCT02438605

Brief Summary

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.

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 Apr 2015

Shorter than P25 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

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 1, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

May 6, 2015

Last Update Submit

June 30, 2016

Conditions

Aortic Aneurysm

Keywords

NellixEVASEVARDynamic CTDyna CT

Outcome Measures

Primary Outcomes (1)

  • Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS

    1 month

Secondary Outcomes (2)

  • Dynamic changes in neck morphology after EVAS

    1 month

  • Dynamic changes in common iliac artery morphology after EVAS.

    1 month

Study Arms (1)

Treatment group

Patients eligible for AAA repair using Nellix and willing to participate in this trial.

Device: Nellix

Interventions

NellixDEVICE
Treatment group

Eligibility Criteria

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

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

You may qualify if:

  • Nellix implantation

You may not qualify if:

  • Use of chimneys or combined with other stent graft material

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate Hospital

Arnhem, 6815AD, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

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

May 6, 2015

First Posted

May 8, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 1, 2016

Record last verified: 2016-06

Locations

NL(1)