Vascular DiseasesACSSimNCT06428877
Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation
An observational study of Vascular Diseases and Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Diseases, Surgery
- What is being tested?
- analyzed on the post-operative scanner
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2023to 15 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered.
Who may be able to join
- The patient:
- Is age ≥18 at the time of inclusion.
- Underwent EVAR with ACS Gore Excluder
- AAA proximal neck angulation superior to 60 degrees
- Pre-op CT and post-operative/follow-up CT available
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- analyzed on the post-operative scanner
- Keywords
- Endoprosthesis, Numerical simulation, Proximal neck
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analyzed on the post-operative scannerOther
analyzed on the post-operative scanner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: analyzed on the post-operative scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 Jun 2023
- Primary completion15 Sep 2023
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06428877
- Sponsor's protocol ID
- 69HCL24_0514
- Acronym
- ACSSim
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation
- ClinicalTrials.gov ID
- NCT06428877
- Acronym / sponsor ID
- ACSSim / 69HCL24_0514
- Conditions
- Vascular Diseases, Surgery
- Keywords
- Endoprosthesis, Numerical simulation, Proximal neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent EVAR with ACS Gore excluder. | – | Other: analyzed on the post-operative scannerPatients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent EVAR with ACS Gore excluder. Only patients with proximal neck angulation superior to 60 degrees will be considered.
Key inclusion criteria (5 listed)
- Is age ≥18 at the time of inclusion.
- Underwent EVAR with ACS Gore Excluder
- AAA proximal neck angulation superior to 60 degrees
- Pre-op CT and post-operative/follow-up CT available
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analyzed on the post-operative scanneranalyzed on the post-operative scanner | Other | Patients who underwent EVAR with ACS Gore excluder. |
Primary outcome
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.
Time frame: up to 16 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Diseases and Surgery, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: up to 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.