Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation (ACSSim)

andated when the risk of rupture is low and interventional treatment is offered to patients at high risk of rupture. Rupture risk is driven by aneurysm diameter and growth rate. Aneurysms with diameter greater than 55 mm and/or growth rate greater than 1 cm per year are at high risk of rupture. Open surgery and endovascular treatment are the two types of interventions. Open repair consists in replacing the aneurysmal part of the aorta using a synthetic fabric prosthesis after the abdomen has been opened and the aorta clamped. This invasive procedure is associated with a 3-10% post-operative mortality. Endovascular repair (EVAR) consists in excluding the aneurysm sac by inserting a self-expanding prosthesis (called stent-graft) through very small groin incisions, without abdominal opening nor aortic clamping. This minimally invasive procedure is associated with a significantly reduced post-operative mortality (around 1%) . However, hostile proximal neck anatomy including high angulation is associated with higher rates of type IA endoleak, reintervention and long-term mortality . For this reason, a conformable design of the Excluder stent-graft has been engineered with initial satisfactory results in patients with highly angulated or short necks . However, these satisfactory results have been obtained in carefully selected patients from experienced centers and a tool demonstrating adequate apposition of the Gore ACS is lacking. Study Device Description Numerical simulation has been used successfully to predict stent-graft behavior during FEVAR . Preliminary studies have also demonstrated to applicability of the technology to standard infrarenal devices , including in the setting of very tortuous anatomies9 . The potential of numerical simulation to predict stent-graft apposition of Gore ACS in highly angulated necks appears very promising to enhance patient selection.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Surgery
• Intervention / Treatment: Other: analyzed on the post-operative scanner

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Hopital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered.

Description

Inclusion Criteria:

The patient:

1. Is age ≥18 at the time of inclusion.
2. Underwent EVAR with ACS Gore Excluder
3. AAA proximal neck angulation superior to 60 degrees
4. Pre-op CT and post-operative/follow-up CT available

Exclusion Criteria:

1. Slice thickness of Pre-op or post-op / follow-up CT superior to 2mm.
2. Non-injected or poorly injected pre-operative CT-scan precluding technical feasibility of the aortic digital twin
3. Absence of post-operative or follow-up CT-scan
4. Patient refusal of his personal information/medical data to be used in the context of the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who underwent EVAR with ACS Gore excluder.; Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered.	Other: analyzed on the post-operative scanner; analyzed on the post-operative scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The aim of the present study is to investigate the accuracy of numerical simulation to predict stent-graft apposition of Gore ACS in highly angulated proximal AAA necks.	Quantitative neck apposition parameters (including but not limited to malapposition length, width, angle) will be extracted both from numerical simulation and post-operative CT. Quantitative values will then be compared Comparison between quantitative neck apposition parameters (malapposition length, width, angle) derived from simulation and the one observed on post-op CT and/ or follow-up CT	up to 16 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: May 16, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Endoprosthesis; Numerical simulation; Proximal neck
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 69HCL24_0514

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No