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OpenTrials
Completed

NCT Number: NCT05536167

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

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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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Louis

La Rochelle, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Efficacy endpoint

    Time frame: up to end of procedure

    successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure.

  2. Safety endpoint

    Time frame: up to end of procedure

    insertion and retrieval of the catheter up to the treated vessel without complication.

Secondary outcomes

  1. Performance - TIMI flow grade

    Time frame: up to end of procedure

    Final Thrombolysis In Myocardial Infarction (TIMI) Flow Grade at procedure

  2. Safety - absence of complications

    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,

  3. Performance - TIMI thrombus grade

    Time frame: up to end of procedure

    Final TIMI Thrombus Grade at procedure

  4. Performance

    Time frame: up to end of procedure

    Distal Embolization Rate at procedure

  5. Safety - absence of Serious Adverse Event

    Time frame: up to end of procedure

    Incident of Device Related SAEs during aspiration catheter use

  6. Safety - absence of stroke

    Time frame: up to end of procedure

    Stroke during aspiration catheter use (per hospital standard of care).

Sponsors and collaborators

Lead sponsor

Arthesys

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2022
Registry last updated
Feb 1, 2024

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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