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

Arthesys

Status: Completed

Conditions: Coronary Artery Stenosis

Study type: Observational

Funder types: Industry

Identifiers

NCT05536180

ART-PTCA-02

Details and patient eligibility

About

The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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 or coronary bypass graft indication
• Patient >18 years
• 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. Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.