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This is an open label, prospective, non-randomised, multi-centre post market study of the POUNCE Venous Thrombectomy system for de-clotting in the peripheral vasculature (e.g., iliofemoral veins).
This PMCF study is designed to further evaluate the safety and performance of the POUNCE Venous Thrombectomy system in the treatment of patients with symptomatic peripheral vascular thrombus through removal of thrombus. The study will collect both qualitative and quantitative data recorded by the investigators during the procedure to further evaluate safety and performance of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pounce Venous Thrombectomy System | Other | Subjects admitted for endovascular thrombus removal using the Pounce Venous Thrombectomy System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pounce Venous Thrombectomy System | Device | The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Performance | Successful preparation and use of the device to achieve flow restoration, i.e., elimination of a minimum of 50% thrombus (SIR Grade II or Grade III) in the treated target venous segment. | 30 days, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nusrath Sultana, MD | Contact | 763-777-2737 | nsultana@surmodics.com | |
| Aliza Avalos | Contact | 209-485-2072 | aavalos@surmodics.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Lichtenberg, MD | Klinikum Hochsauerland GmbH | Principal Investigator |
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