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| Name | Class |
|---|---|
| Eclevar Medtech | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endarterectomy | Device | 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. |
| 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 ) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rate |
| within 30 days after surgery and long term (up to 1 year after surgery ) |
| target-artery restenosis Target-artery restenosis |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Armel Plaine, Master | Eclevar Medtech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eclevar Medtech | Paris | 75017 | France |
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| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D001157 | Arterial Occlusive Diseases |
| D020521 | Stroke |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004691 | Endarterectomy |
| D016894 | Endarterectomy, Carotid |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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 |
| 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 |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |