ART-PCTA-02 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 of the Arthesys PTCA non-compliant catheters family will be collected during angioplasty intervention of coronary vessels or coronary bypass graft stenosis.
Sponsor
ARTHESYS
Study objectives
The purpose of this post market study is to collect clinical data of the Arthesys PTCA non-compliant catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
Primary endpoints
Define the Efficacy of the medical device described as: Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter.
Define the Safety of the medical device described as: Successful balloon dilatation without device related adverse event during the dilatation procedure.
CERC Services
- Core Laboratory
- Hospital Contracts Management
- Monitoring activities
- Statistical Activities
- Study documents draft and review
Countries
France
Number of investigational sites
4
