NCT02440113

Brief Summary

Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix Endoprosthesis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

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

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

8 months

First QC Date

January 12, 2015

Last Update Submit

July 14, 2016

Conditions

Abdominal Aortic AneurysmEndovascular Aortic RepairNellix Endovascular Sealing

Outcome Measures

Primary Outcomes (5)

  • Changes in the infrarenal neck morphology (below the renal arteries)

    1 year

  • Changes in the thrombus in the aneurysm sac

    1 year

  • Changes in the aneurysm wall and geometry

    1 year

  • Changes in the cobalt-chromium stent and their lumen

    1 year

  • Changes in the polymer-filled endobags Using anonymous patient data a database will be created an securely stored. Patient consent for study participation will be attained before accessing patient files

    1 year

Study Arms (1)

Nellix

Patients with endovascular Nellix repair

Device: Nellix

Interventions

NellixDEVICE

Nellix Implantation

Nellix

Eligibility Criteria

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

Patients who underwent Nellix endovascular aortic repair

You may qualify if:

  • Patients who underwent endovascular abdominal aneurysm repair using the Nellix endoprosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Michel Reijnen, MD, PhD

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 12, 2015

First Posted

May 12, 2015

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 15, 2016

Record last verified: 2016-07