Aneurysm AbdominalNCT05519826
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
An observational study of Aneurysm Abdominal and Peripheral Aneurysms, run by Perouse Medical at 1 site in France.
Trial summary
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aneurysm Abdominal, Peripheral Aneurysms, Arterial Disease Occlusive
- What is being tested?
- Vascular surgery
- Type of treatment
- Medical device
- How many people
- 373 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 20 Apr 2022
- 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: Patient population conditions that may indicate abdominal and/or peripheral vascular open surgical repair with implantation of a POLYMAILLE EXTRA THIN vascular graft include: * Peripheral arterial diseases (PAD), characterized by reduced blood flow to the lower extremities, which may be categorized as: * Intermittent claudication (IC) * Chronic limb-threatening ischemia (CLTI) * Acute limb ischemia (ALI) * Peripheral arterial aneurysms, characterized by a permanent localized (i.e., focal) modification of the parallelism of the vessel walls, which may be categorized by the following location: * Iliac arterial aneurysms (IAA) * Femoral arterial aneurysms (FAA) * Popliteal arterial aneurysms (PAA)
Who may be able to join
- Patients must meet all 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
- Patients who refused the collection of their personal data.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.
the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.
- Being tested
- Vascular surgery
- Medical subject headings
- Aortic Aneurysm, Abdominal, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular surgeryDevice
POLYMAILLE® EXTRA THIN vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.
Abdominal vascular surgery includes aorto-iliac and/or aorto-femoral vascular repair, i.e. graft implantation with proximal anastomosis to abdominal aorta (supra and/or infra-renal).
Peripheral vascular surgery includes peripheral arteries repair, i.e. graft implantation with no aortic anastomosis, and/or extra-anatomic vascular repair such as axillo-femoral and/or crossover bypass (femoro-femoral and/or ilio-femoral) and/or femoro-popliteal bypass above the knee.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary performance endpoint
primary patency rate
Measured: 1 year
Primary safety endpoint
limb salvage rate
Measured: 1 year
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
patent grafts without any procedure or intervention of the conduit itself
Measured: 5 years
Primary assisted patency rate
rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, however with graft never thrombosed (graft occlusion)
Measured: 5 years
-Secondary patency rate
rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, lysis and/or thrombectomy
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
freedom % from target limb major amputation
Measured: 5 years
Adverse events
any documented adverse events, including anticipated (as listed in section 6.2) 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 posted29 Aug 2022
- Study start1 Mar 2022
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm AbdominalStudies 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
- 373 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
- NCT05519826
- Sponsor's protocol ID
- PMET-2022-01
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
- ClinicalTrials.gov ID
- NCT05519826
- Acronym / sponsor ID
- PMET-2022-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Perouse MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 29 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.
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.
the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient population conditions that may indicate abdominal and/or peripheral vascular open surgical repair with implantation of a POLYMAILLE EXTRA THIN vascular graft include: * Peripheral arterial diseases (PAD), characterized by reduced blood flow to the lower extremities, which may be categorized as: * Intermittent claudication (IC) * Chronic limb-threatening ischemia (CLTI) * Acute limb ischemia (ALI) * Peripheral arterial aneurysms, characterized by a permanent localized (i.e., focal) modification of the parallelism of the vessel walls, which may be categorized by the following location: * Iliac arterial aneurysms (IAA) * Femoral arterial aneurysms (FAA) * Popliteal arterial aneurysms (PAA)
Key inclusion criteria (2 listed)
- Patients must meet all 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)
- Patients who refused the collection of their personal data.
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 |
|---|---|---|
| Vascular surgeryPOLYMAILLE® EXTRA THIN vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease. Abdominal vascular surgery includes aorto-iliac and/or aorto-femoral vascular repair, i.e. graft implantation with proximal anastomosis to abdominal aorta (supra and/or infra-renal). Peripheral vascular surgery includes peripheral arteries repair, i.e. graft implantation with no aortic anastomosis, and/or extra-anatomic vascular repair such as axillo-femoral and/or crossover bypass (femoro-femoral and/or ilio-femoral) and/or femoro-popliteal bypass above the knee. | Device | – |
Primary outcome
Primary performance endpoint
Time frame: 1 year
primary patency rate
Primary safety endpoint
Time frame: 1 year
limb salvage rate
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 rate
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 29 Aug 2022.
- Individual participant dataSharing planned: No
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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 Aneurysm Abdominal and Peripheral Aneurysms, run by Perouse Medical 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 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 29 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 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?
Primary performance endpoint (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 29 Aug 2022.