SurgeryProxSimNCT05944835
Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents
An observational study of Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Endoprosthesis treatment of aortic pathologies has become the reference in the vast majority of situations. The success of this treatment is conditioned by the choice of the endoprosthesis which must be as adapted as possible to the anatomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surgery
- What is being tested?
- Analyzed on the post-operative scanner
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2023to 15 Dec 2023
- 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: Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder
Who may be able to join
- Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder
Who cannot join
- Patient who has objected to the use of their data.
- No preoperative scanner available or insufficient injection quality
- Preoperative scanner with slice thickness greater than 3 mm
Trial locations and contacts
1 site in 1 country.
About this study
Endoprosthesis treatment of aortic pathologies has become the reference in the vast majority of situations. The success of this treatment is conditioned by the choice of the endoprosthesis which must be as adapted as possible to the anatomy. This choice is currently based on manual geometric measurements performed on the preoperative scanner using conventional image processing software.
The morphological result of the implantation of the endoprosthesis in the aorta is obtained by a CT scan carried out postoperatively. This scanner makes it possible to define the positioning of the endoprosthesis, the apposition surfaces between the aorta and the endoprosthesis and to predict the long-term result.
- Conditions
- Surgery
- Being tested
- Analyzed on the post-operative scanner
- Keywords
- Endoprosthesis, proximal neck, numerical simulation
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 |
|---|---|---|
| Patient who has been treated for an aortoiliac aneurysm | Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder 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 accuracy of numerical simulation to predict the deployment at the level of the proximal neck of different types of standard stents used for the treatment of an aortoiliac aneurysm.
Wwill be evaluated by measuring the diameter and the position of the center of the first 3 simulated proximal stents will be compared to those of the real stents, analyzed on the post-operative scanner
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 Feb 2023
- Primary completion15 Aug 2023
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- 15 participants (estimated)
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
- NCT05944835
- Sponsor's protocol ID
- 69HCL23_0342
- Acronym
- ProxSim
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Numerical Simulation to Predict Proximal Deployment of Standard Stents
- ClinicalTrials.gov ID
- NCT05944835
- Acronym / sponsor ID
- ProxSim / 69HCL23_0342
- Conditions
- Surgery
- Keywords
- Endoprosthesis, proximal neck, numerical simulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 13 Jul 2023 (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.
Endoprosthesis treatment of aortic pathologies has become the reference in the vast majority of situations. The success of this treatment is conditioned by the choice of the endoprosthesis which must be as adapted as possible to the anatomy. This choice is currently based on manual geometric measurements performed on the preoperative scanner using conventional image processing software.
The morphological result of the implantation of the endoprosthesis in the aorta is obtained by a CT scan carried out postoperatively. This scanner makes it possible to define the positioning of the endoprosthesis, the apposition surfaces between the aorta and the endoprosthesis and to predict the long-term result.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient who has been treated for an aortoiliac aneurysm | – | Other: Analyzed on the post-operative scannerAny patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder
Key inclusion criteria (1 listed)
- Any patient who has been treated for an aortoiliac aneurysm with a standard Medtronic Endurant aortic stent, standard Gore Excluder or conformable Gore Excluder
Key exclusion criteria (3 listed)
- Patient who has objected to the use of their data.
- No preoperative scanner available or insufficient injection quality
- Preoperative scanner with slice thickness greater than 3 mm
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 | Patient who has been treated for an aortoiliac aneurysm |
Primary outcome
The accuracy of numerical simulation to predict the deployment at the level of the proximal neck of different types of standard stents used for the treatment of an aortoiliac aneurysm.
Time frame: through study completion, an average of 1 year
Wwill be evaluated by measuring the diameter and the position of the center of the first 3 simulated proximal stents will be compared to those of the real stents, analyzed on the post-operative scanner
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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?
Results are not available in the source record.
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 accuracy of numerical simulation to predict the deployment at the level of the proximal neck of different types of standard stents used for the treatment of an aortoiliac aneurysm. (time frame: through study completion, an average of 1 year). 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 13 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.