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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy endpoint | Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter | up to end of procedure |
| Safety endpoint | Successful balloon dilatation without device related adverse event during the dilatation procedure | up to end of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Performance - Pre-dilatation | Residual stenosis < 50% and TIMI flow grade 3 (corelab assessment) | up to end of procedure |
| Performance - post-dilatation | Angiographic success of the device defined as < 30% residual stenosis after angiography (corelab assessment) |
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Inclusion Criteria:
Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):
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.
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Patients undergoing PTCA procedure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Saint Louis | La Rochelle | France |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| up to end of procedure |
| D014652 |
| Vascular Diseases |