Artery Stenosis, CarotidNCT04643743
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
An observational study of Artery Stenosis, Carotid and Artery Stenosis, run by Perouse Medical at 1 site in France.
Trial summary
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population. All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery
- What is being tested?
- Endarterectomy
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 10 Jun 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators will screen all potential subjects and will select those who are appropriate for study inclusion, i.e. adult subjects implanted with POLYPATCH® for at least one year. All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery. A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.
Who may be able to join
- Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty
- Subjects ≥ 18 years old
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.
All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery.
A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.
- Conditions
- Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery, Stroke
- Being tested
- Endarterectomy
- Keywords
- vascular patch, Polypatch, femoral endarterectomy, carotid endarterectomy, Thrombosis
- Medical subject headings
- Carotid Stenosis, Arterial Occlusive Diseases, Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndarterectomyDevice
Also called Carotid Endarterectomy, Femoral Endarterectomy, Patch Angioplasty
Endarterectomy is a surgical procedure to remove the atheromatous plaque material, or blockage, in the lining of an artery constricted by the buildup of deposits. It is carried out by separating the plaque from the arterial wall.
| Study group | Role | What they receive |
|---|---|---|
| Subjects who did receive POLYPATCH® for vascular angioplasty | Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty. 2 main sub-populations will be studied depending on location of surgery (carotid and femoral) but data will be collected for all subjects who did receive POLYPATCH. Receives: Device: Endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change rate of restenosis
Measure assessing change target-artery restenosis (defined as 70% or more diameter-reducing stenosis), occlusion, or re-intervention within 1 year after surgery using POLYPATCH®
Measured: within 30 days after surgery and long term (up to 1 year after surgery )
Secondary outcomes (9)
Procedural success rate
- ability to use with no need for using another device,
- effective vascular closure after endarterectomy procedure,
- no need to re-operate before patient discharge
Measured: within 30 days after surgery and long term (up to 1 year after surgery )
target-artery restenosis Target-artery restenosis
Restenosis can be identified by echo-doppler, CT scan or angiography evaluating the percentage of lumen of vessel but can also be classified as symptomatic vs asymptomatic and/or requiring or not re-intervention.
Measured: within 30 days after surgery and long term (up to 3 years)
target-artery re-intervention
- angioplasty and stenting,
- surgical bypass,
- thrombectomy and re-do patchoplasty,
- evacuation of hematoma.
Measured: within 30 days after surgery and long term (up to 3 years)
stroke (ipsilateral and any)
Stroke is a risk inherent to any surgical intervention, especially vascular surgeries. Although uncommon, stroke in the perioperative period is associated with significant morbidity and mortality in the CEA patient population
Measured: within 30 days after surgery and long term (up to 3 years)
transient ischemic attack
within 30 days after surgery and long term (up to 3 years)
Measured: 3 years
myocardial infarction
within 30 days after surgery and long term (up to 3 years)
Measured: 3 years
mortality (cardiovascular and all causes)
Death is the most dramatic complication one can encounter after vascular procedure. It can result from ipsilateral stroke caused by restenosis or thrombi, patch rupture caused by patch infection, or secondary cardiovascular or neurologic risks caused by the surgery itself
Measured: within 30 days after surgery and long term (up to 3 years)
occurrence of other complications
within 30 days after surgery and long term (up to 3 years)
Measured: within 30 days after surgery and long term (up to 3 years)
Operation time
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Sep 2020
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artery Stenosis, CarotidStudies 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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perouse Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Responsible party
- Sponsor
- Investigators
- Armel Plaine, Master, Study director, Eclevar Medtech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643743
- Sponsor's protocol ID
- 2020-POL-01
- Status last verified
- Aug 2022
- First submitted
- 1 Nov 2020
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
- ClinicalTrials.gov ID
- NCT04643743
- Acronym / sponsor ID
- 2020-POL-01
- Conditions
- Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery, Stroke
- Keywords
- vascular patch, Polypatch, femoral endarterectomy, carotid endarterectomy, Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Perouse MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Eclevar Medtech
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 25 Nov 2020 (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.
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.
All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery.
A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who did receive POLYPATCH® for vascular angioplasty | – | Device: EndarterectomySubjects who did receive POLYPATCH® at least one year ago for vascular angioplasty. 2 main sub-populations will be studied depending on location of surgery (carotid and femoral) but data will be collected for all subjects who did receive POLYPATCH. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will screen all potential subjects and will select those who are appropriate for study inclusion, i.e. adult subjects implanted with POLYPATCH® for at least one year. All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery. A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.
Key inclusion criteria (2 listed)
- Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty
- Subjects ≥ 18 years old
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 |
|---|---|---|
| EndarterectomyAlso: Carotid Endarterectomy, Femoral Endarterectomy, Patch AngioplastyEndarterectomy is a surgical procedure to remove the atheromatous plaque material, or blockage, in the lining of an artery constricted by the buildup of deposits. It is carried out by separating the plaque from the arterial wall. | Device | Subjects who did receive POLYPATCH® for vascular angioplasty |
Primary outcome
Change rate of restenosis
Time frame: within 30 days after surgery and long term (up to 1 year after surgery )
Measure assessing change target-artery restenosis (defined as 70% or more diameter-reducing stenosis), occlusion, or re-intervention within 1 year after surgery using POLYPATCH®
9 secondary outcomes
Procedural success rate
Time frame: within 30 days after surgery and long term (up to 1 year after surgery )
target-artery restenosis Target-artery restenosis
Time frame: within 30 days after surgery and long term (up to 3 years)
target-artery re-intervention
Time frame: within 30 days after surgery and long term (up to 3 years)
stroke (ipsilateral and any)
Time frame: within 30 days after surgery and long term (up to 3 years)
transient ischemic attack
Time frame: 3 years
myocardial infarction
Time frame: 3 years
mortality (cardiovascular and all causes)
Time frame: within 30 days after surgery and long term (up to 3 years)
occurrence of other complications
Time frame: within 30 days after surgery and long term (up to 3 years)
Operation time
Time frame: up to 24 weeks
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 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.
Armel Plaine, Master study director
Eclevar Medtech
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 Artery Stenosis, Carotid and Artery Stenosis, 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 24 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?
Change rate of restenosis (time frame: within 30 days after surgery and long term (up to 1 year after surgery )). 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 Aug 2022.