ART-ASPI CATHETER-01 study is an observational, prospective, post-market, single arm, open label, multicentre study. Within this trial, 60 patients are planned to be enrolled. During the trial, clinical data will be collected and evaluated from the use of the aspiration catheter during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system.
Sponsor
ARTHESYS
Study objectives
The objective of this post market study is to confirm the safety and the performance of the Aspiration Catheter during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts.
Primary endpoints
Define the Efficacy of the medical device described as: successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure.
Define the Safety of the medical device described as: insertion and retrieval of the catheter up to the treated vessel without complication.
CERC Services
- Hospital Contracts Management
- Monitoring activities
- Statistical Activities
- Study documents draft and review
Countries
France
Number of investigational sites
4
