NCT03469245

Brief Summary

Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

Trial Health

93
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 Apr 2018

Geographic Reach
5 countries

9 active sites

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

First Submitted

Initial submission to the registry

February 19, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 26, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2019

Completed
Last Updated

June 22, 2023

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

February 19, 2018

Last Update Submit

June 19, 2023

Conditions

Abdominal Aortic Aneurysms

Keywords

EndovascularFenestrated endovascular repairnumerical simulation

Outcome Measures

Primary Outcomes (1)

  • Vascutek in vitro validation test and the numerical simulation

    To compare Vascutek in vitro validation test and the numerical simulation (Predisurge). The proportion of fenestrations is less or equal to 2.5mm will be calculated.

    Months: 18

Secondary Outcomes (2)

  • initial and final stent-graft designs obtained from Vascutek

    Months: 18

  • stent-graft designs obtained from simulation of deployment

    Months: 18

Study Arms (1)

abdominal aortic aneurysms treated by fenestrated endovascular

Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included. Predisurge society will perform numerical simulation.

Other: numerical simulation

Interventions

numerical simulationOTHER

After patients have been treated by fenestrated endovascular of society Vascutek data will be collected by society Vascutek and send to Predisurge society. They will perform numerical simulation and compare with the method of Vascutek.

abdominal aortic aneurysms treated by fenestrated endovascular

Eligibility Criteria

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

Patients have an abdominal aortic aneurysms treated by fenestrated endovascular anacondaTM of society Vascutek will be included.

You may qualify if:

  • \- abdominal aortic aneurysms suitable for treatment using Fenestrated AnacondaTM (Vascutek) device

You may not qualify if:

  • failure to generate an adequate FE model of patient arteries (no preoperative multidetector contrast-enhanced CT-scan available, preoperative CT-scan slice thickness greater than 1mm, preoperative CT-scan with artifacts)
  • stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning
  • patient refusing to participate to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Wilhelminen hospital

Vienna, Austria

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Lyon

Lyon, France

Location

Hôpitaux privés de Metz

Metz, France

Location

Chu Saint-Etienne

Saint-Etienne, France

Location

University Hospital, Campus Benjamin Franklin

Berlin, Germany

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

University Hospital Utrecht

Utrecht, Netherlands

Location

Derby Hospital

Derby, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Bertrand CHAVENT, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 19, 2018

Study Start

April 26, 2018

Primary Completion

September 4, 2019

Study Completion

September 22, 2019

Last Updated

June 22, 2023

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)AU(1)NL(2)GB(1)FR(4)