Artery Stenosis, Artery Stenosis, Carotid, Occlusion of Artery, Stroke
Conditions
Keywords
vascular patch, Polypatch, femoral endarterectomy, carotid endarterectomy, Thrombosis
Brief 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. 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.
Interventions
DEVICEEndarterectomy
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.
Sponsors
Eclevar Medtech
Perouse Medical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty * Subjects ≥ 18 years old
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change rate of restenosis | 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® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| target-artery restenosis Target-artery restenosis | within 30 days after surgery and long term (up to 3 years) | 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. |
| target-artery re-intervention | within 30 days after surgery and long term (up to 3 years) | * angioplasty and stenting, * surgical bypass, * thrombectomy and re-do patchoplasty, * evacuation of hematoma. |
| stroke (ipsilateral and any) | within 30 days after surgery and long term (up to 3 years) | 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 |
| transient ischemic attack | 3 years | within 30 days after surgery and long term (up to 3 years) |
| Procedural success rate | within 30 days after surgery and long term (up to 1 year after surgery ) | * ability to use with no need for using another device, * effective vascular closure after endarterectomy procedure, * no need to re-operate before patient discharge |
| mortality (cardiovascular and all causes) | within 30 days after surgery and long term (up to 3 years) | 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 |
| 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 | — |
| myocardial infarction | 3 years | within 30 days after surgery and long term (up to 3 years) |
Countries
France
Outcome results
None listed