Hôpital Saint Louis
La Rochelle, France
NCT Number: NCT05536167
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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Observational
La Rochelle, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to end of procedure
successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure.
Time frame: up to end of procedure
insertion and retrieval of the catheter up to the treated vessel without complication.
Time frame: up to end of procedure
Final Thrombolysis In Myocardial Infarction (TIMI) Flow Grade at procedure
Time frame: up to end of procedure
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,
Time frame: up to end of procedure
Final TIMI Thrombus Grade at procedure
Time frame: up to end of procedure
Distal Embolization Rate at procedure
Time frame: up to end of procedure
Incident of Device Related SAEs during aspiration catheter use
Time frame: up to end of procedure
Stroke during aspiration catheter use (per hospital standard of care).
Arthesys
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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