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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

• Study Contact: Name: Laure Morsiani; Phone Number: 0176739236; Email: lmorsiani@cerc-europe.org

Study Locations

• France
  • La Rochelle, France
    • Hôpital Saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing PTA/PTCA and/or stenting procedures and presenting thrombus in the central and peripheral circulatory system, including saphenous vein grafts.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arthesys

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: ART-ASPI CATHETER-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No