Aneurysm ArterialNCT05516043
Safety and Performance of POLYTHESE® Vascular Prosthesis
An observational study of Aneurysm Arterial and Peripheral Arterial Disease, run by Perouse Medical at 3 sites in France.
Trial summary
POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device. PMCF Study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aneurysm Arterial, Peripheral Arterial Disease, Marfan Syndrome
- What is being tested?
- Implantation with POLYTHESE®
- Type of treatment
- Surgery or procedure
- How many people
- 256 participants
- Where
- 3 sitesFrance
- Study dates
- 7 Jul 2021to 26 Nov 2021
- 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
- Child, Adult, Older adult
Study population: all potential subjects who are appropriate for study inclusion, i.e. subjects implanted with POLYTHESE® for at least one year, or with complete data to death. As the study explores real world data, there is no exclusion criteria for subjects and all subjects with POLYTHESE® implanted for at least one year and have not objected to the collect of their data will be included in the study.
Who may be able to join
- Patients must meet the following inclusion criteria in order to be eligible for inclusion in the study:
- Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU CAEN
Caen, 14000
CHU de NANTES
Nantes, 44000
CHU La Pitié Salpétrière
Paris, 75014
About this study
Official title: A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses
POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device.
PMCF Study.
- Conditions
- Aneurysm Arterial, Peripheral Arterial Disease, Marfan Syndrome, Arterial Dissections, Ehlers-Danlos Syndrome
- Being tested
- Implantation with POLYTHESE®
- Medical subject headings
- Peripheral Arterial Disease, Marfan Syndrome, Dissection, Blood Vessel, Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation with POLYTHESE®Procedure or surgery
thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance: Primary patency rate
Patency rate
Measured: 1 year
Safety : Mortality rate
Measured: 30 days
Secondary outcomes (8)
Procedural success rate
Ability to use with no need for replacement by another device and, Effective vascular flow restoration after procedure and, In case of aneurysm, exclusion of aneurysmal portion after procedure.
Measured: 5 years
Primary patency rate
rate patency of the bypass graft without procedure or intervention of the conduit itself (except for occlusion)
Measured: 5 years
Primary assisted patency rate
defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself (except for occlusion) after device implantation
Measured: 5 years
Secondary patency
defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself for occlusion after device implantation
Measured: 5 years
Device Failure
- Uncontrolled blood leakage from device
- Loss of structural integrity, e.g. rupture and/or exaggerated dilation (> 50 %)
- Occlusion of the device
- Total or partial replacement of the device required
Measured: 5 years
Mortality rate
freedom % from death
Measured: 5 years
Limb salvage rate
defined as freedom % from target limb amputation
Measured: 5 years
Adverse events
any documented adverse events, including anticipated and non-anticipated adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start7 Jul 2021
- Primary completion21 Oct 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm ArterialStudies of the same condition, open and under way.
- 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
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perouse Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516043
- Sponsor's protocol ID
- 2021-PT-01
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 25 Aug 2022
- 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 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses
- ClinicalTrials.gov ID
- NCT05516043
- Acronym / sponsor ID
- 2021-PT-01
- Conditions
- Aneurysm Arterial, Peripheral Arterial Disease, Marfan Syndrome, Arterial Dissections, Ehlers-Danlos Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Perouse MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 25 Aug 2022 (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.
POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device.
PMCF Study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all potential subjects who are appropriate for study inclusion, i.e. subjects implanted with POLYTHESE® for at least one year, or with complete data to death. As the study explores real world data, there is no exclusion criteria for subjects and all subjects with POLYTHESE® implanted for at least one year and have not objected to the collect of their data will be included in the study.
Key inclusion criteria (2 listed)
- Patients must meet the following inclusion criteria in order to be eligible for inclusion in the study:
- Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Implantation with POLYTHESE®thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery | Procedure or surgery | – |
Primary outcome
Performance: Primary patency rate
Time frame: 1 year
Patency rate
Safety : Mortality rate
Time frame: 30 days
8 secondary outcomes
Procedural success rate
Time frame: 5 years
Primary patency rate
Time frame: 5 years
Primary assisted patency rate
Time frame: 5 years
Secondary patency
Time frame: 5 years
Device Failure
Time frame: 5 years
Mortality rate
Time frame: 5 years
Limb salvage rate
Time frame: 5 years
Adverse events
Time frame: 5 years
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 25 Aug 2022.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Arterial and Peripheral Arterial Disease, run by Perouse Medical at 3 sites 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 2 inclusion and 1 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Performance: Primary patency rate (time frame: 1 year). The study lists 2 primary outcomes in all. 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 25 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.