A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch

Study Overview
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Brief Summary
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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.

Official Title
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A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch

Conditions
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Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery, Stroke

Intervention / Treatment
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* Device: Endarterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty Subjects ≥ 18 years old Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects who did receive POLYPATCH® for vascular angioplasty<br>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<br>* 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.<br>* Other names: Patch Angioplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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® | within 30 days after surgery and long term (up to 1 year after surgery ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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 | 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) | 3 years | 
| myocardial infarction | within 30 days after surgery and long term (up to 3 years) | 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 | 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) | within 30 days after surgery and long term (up to 3 years) | 
| Operation time |  | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular patch, Polypatch, femoral endarterectomy, carotid endarterectomy, Thrombosis