NCT04244188

Brief Summary

Total endovascular repair of the aortic arch represents a promising option for patients ineligible to open surgery. Custom-made design of stent-grafts (SG), such as the Terumo Aortic® RelayBranch device (DB), requires complex preoperative measures. Accurate SG deployment is required to avoid intraoperative or postoperative complications, which is extremely challenging in the aortic arch. In that context, the investigators aim is to develop a computational tool able to predict SG deployment in such highly complex situations. Four patient-specific cases will be performed with complete deployment of the DB and its bridging stents in aneurysmal aortic arch. Deviations of simulation predictions from actual stent positions will be estimated based on post-operative scan and a sensitivity analysis will be performed to assess the effects of material parameters. If good agreement between simulation and reality is obtained, numerical simulations will show their ability to successfully predict the DB deployment in complex anatomy. The results will emphasize the potential of computational simulations to assist practitioners in planning and performing complex and secure interventions.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
2 countries

2 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

Study Start

First participant enrolled

January 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

January 24, 2020

Last Update Submit

November 17, 2023

Conditions

Aortic Arch Aneurysm

Keywords

Numerical simulationstent-graftaortic arch aneurysms

Outcome Measures

Primary Outcomes (1)

  • In vitro versus stimulation test

    To compare Vascutek in vitro validation test to the simulation of this test, the proportion of fLenestrations where \|L3 - L2\| and \|C3 - C2\| are less or equal to 2.5mm will be analysed. L3=distal edge of celiac trunk (L) after first simulation, stent-graft deployment in rigid aorta L2=distal edge of celiac trunk (L) after final custom stent-graft design, after in vitro tests

    Day 0

Study Arms (1)

Patients treated for aortic arch aneurysms

Patients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included.

Other: Collection of datas

Interventions

Collection of datasOTHER

Collection of datas: pre- and postoperative scanner and endoprosthesis characteristics

Patients treated for aortic arch aneurysms

Eligibility Criteria

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

Patients treated for aortic arch aneurysms by double branched endovascular repair (Bolton Medical) will be included.

You may qualify if:

  • Aortic arch aneurysms suitable for treatment using double-branched device Bolton

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)
  • dissected aneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Saint-Etienne

Saint-Etienne, France

Location

Rinjstate Hopital

Arnhem, Netherlands

Location

Related Publications (1)

  • Derycke L, Perrin D, Cochennec F, Albertini JN, Avril S. Predictive Numerical Simulations of Double Branch Stent-Graft Deployment in an Aortic Arch Aneurysm. Ann Biomed Eng. 2019 Apr;47(4):1051-1062. doi: 10.1007/s10439-019-02215-2. Epub 2019 Jan 31.

    PMID: 30706308RESULT

MeSH Terms

Conditions

Aneurysm, Aortic Arch

Condition Hierarchy (Ancestors)

Aortic Aneurysm, ThoracicAortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Jean-Noël ALBERTINI, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

January 1, 2019

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)FR(1)