Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family

Conditions
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Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts

Participation Criteria
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Eligibility Criteria
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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): Patient with a percutaneous intervention to a native coronary, saphenous vein graft, or peripheral arteries; Patient with angiographic evidence of thrombus; Patient > or = 50 kg; Patient >18 years; Patient who understands the trial requirements and the treatment procedures and provides written informed consent. Exclusion Criteria: Patients will be excluded as per IFU, Hospital standard of care and GCP, also if there are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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, | 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 |