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

NCT06428877 | Completed

• 1 other identifier: 69HCL24_0514
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Diseases; Surgery

Keywords

Endoprosthesis; Numerical simulation; Proximal neck

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

analyzed on the post-operative scanner OTHER

analyzed on the post-operative scanner

Patients who underwent EVAR with ACS Gore excluder.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• The patient:
• Underwent EVAR with ACS Gore Excluder
• AAA proximal neck angulation superior to 60 degrees
• Pre-op CT and post-operative/follow-up CT available

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, 69500, France

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 24, 2024
• Study Start: June 15, 2023
• Primary Completion: September 15, 2023
• Study Completion: April 15, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

FR (1)