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The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint | successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure. | up to end of procedure |
| Safety endpoint | insertion and retrieval of the catheter up to the treated vessel without complication. | up to end of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Performance - TIMI flow grade | Final Thrombolysis In Myocardial Infarction (TIMI) Flow Grade at procedure | up to end of procedure |
| Safety - absence of complications | Absence of complications during hospitalization (per standard hospital of care): cardiovascular death, recurrent myocardial infarction, cardiogenic shock, worsening of TIMI flow due to aspiration catheter, new or worsening New York Heart Association (NYHA) Class IV heart failure, |
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Inclusion Criteria:
Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):
Exclusion Criteria:
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Patients undergoing PTA/PTCA and/or stenting procedures and presenting thrombus in the central and peripheral circulatory system, including saphenous vein grafts.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Louis | La Rochelle | France |
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| up to end of procedure |
| Performance - TIMI thrombus grade | Final TIMI Thrombus Grade at procedure | up to end of procedure |
| Performance | Distal Embolization Rate at procedure | up to end of procedure |
| Safety - absence of Serious Adverse Event | Incident of Device Related SAEs during aspiration catheter use | up to end of procedure |
| Safety - absence of stroke | Stroke during aspiration catheter use (per hospital standard of care). | up to end of procedure |