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The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Transluminal Coronary Angioplasty | Procedure | Angioplasty intervention of coronary vessels or coronary bypass graft stenosis |
| 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 PTCA procedure |
| Safety endpoint | Successful balloon dilatation without device related adverse event during the dilatation procedure | Up to end of PTCA procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Performance - pre-dilatation | Residual stenosis < 50% and TIMI flow grade 3 | Up to end of PTCA procedure |
| Performance - post-dilatation | Angiographic success of the device defined as <30% residual stenosis after angiography |
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Inclusion Criteria:
Exclusion Criteria:
- 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 |
|---|---|---|---|---|---|---|
| Hôpital Saint Louis | La Rochelle | 17000 | 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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| ID | Term |
|---|---|
| D015906 | Angioplasty, Balloon, Coronary |
| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
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| Up to end of PTCA procedure |
| D014652 |
| Vascular Diseases |
| D009204 |
| Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D062645 | Percutaneous Coronary Intervention |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D008919 | Investigative Techniques |