NCT05536167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

September 7, 2022

Last Update Submit

January 31, 2024

Conditions

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

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Performance - TIMI flow grade

    up to end of procedure

  • Safety - absence of complications

    up to end of procedure

  • Performance - TIMI thrombus grade

    up to end of procedure

  • Performance

    up to end of procedure

  • Safety - absence of Serious Adverse Event

    up to end of procedure

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Louis

La Rochelle, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2022

First Posted

September 10, 2022

Study Start

December 12, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

FR(1)