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

Completed

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

• Registration Number: NCT05536167
• Lead Sponsor: Arthesys

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Study Start: 2022-12-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):

  1. Patient with a percutaneous intervention to a native coronary, saphenous vein graft, or peripheral arteries;
  2. Patient with angiographic evidence of thrombus;
  3. Patient > or = 50 kg;
  4. Patient >18 years;
  5. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy endpoint	up to end of procedure	successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure.
Safety endpoint	up to end of procedure	insertion and retrieval of the catheter up to the treated vessel without complication.

Secondary Outcome Measures

Name	Time	Method
Performance - TIMI thrombus grade	up to end of procedure	Final TIMI Thrombus Grade at procedure
Performance	up to end of procedure	Distal Embolization Rate at procedure
Performance - TIMI flow grade	up to end of procedure	Final Thrombolysis In Myocardial Infarction (TIMI) Flow Grade at procedure
Safety - absence of Serious Adverse Event	up to end of procedure	Incident of Device Related SAEs during aspiration catheter use
Safety - absence of stroke	up to end of procedure	Stroke during aspiration catheter use (per hospital standard of care).
Safety - absence of complications	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,

Trial Locations

Locations (1)

Hôpital Saint Louis; 🇫🇷 La Rochelle, France