An observational study in Vascular Diseases and Surgery, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Hospices Civils de Lyon · Observational
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.
1,036 studies on the registry are indexed under Vascular Diseases; 166 are open to participants now.
This study's enrollment of 20 is below the median of 200 across 304 observational studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.
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Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered.
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The patient:
Exclusion Criteria:
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
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
Time frame: up to 16 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Sep 2023, 3 months.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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