Coronary Artery Stenosis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Arthesys
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy endpoint | up to end of procedure | Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter |
| Safety endpoint | up to end of procedure | Successful balloon dilatation without device related adverse event during the dilatation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance - Pre-dilatation | up to end of procedure | Residual stenosis \< 50% and TIMI flow grade 3 (corelab assessment) |
| Performance - post-dilatation | up to end of procedure | Angiographic success of the device defined as \< 30% residual stenosis after angiography (corelab assessment) |
Countries
France
Outcome results
None listed