An observational study in Artery Stenosis, Carotid, Artery Stenosis and Occlusion of Artery, sponsored by Perouse Medical. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-08-24.
Sponsored by Perouse Medical · Observational
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.
349 studies on the registry are indexed under Carotid Stenosis; 82 are open to participants now.
This study's enrollment of 198 is above the median of 175 across 147 observational studies indexed under Carotid Stenosis.
Browse Carotid Stenosis studies →Perouse Medical is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Endarterectomy
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.
Also known as: Carotid Endarterectomy, Femoral Endarterectomy, Patch Angioplasty
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®
Time frame: within 30 days after surgery and long term (up to 1 year after surgery )
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 3 years
myocardial infarction
within 30 days after surgery and long term (up to 3 years)
Time frame: 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
Time frame: 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)
Time frame: within 30 days after surgery and long term (up to 3 years)
Operation time
Time frame: up to 24 weeks
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Perouse Medical