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| Name | Class |
|---|---|
| EVAMED | OTHER |
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The rationale for this observatory is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent System in Real World CAD Patients with follow-up at 12 months. All medications and procedures to be used/ performed in this observatory are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Device | The Vivo ISAR is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of target lesion failure | • The rate of target lesion failure at 12 months follow-up defined as the composite endpoint of:
| 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device success rate | • Device success rate defined as successful placement and deployment of the device at the target lesion site with successful removal of the delivery system leaving a final residual stenosis <30% of the segment of the culprit lesion covered by the stent at 1 year | 12 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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all-comers population who qualify for percutaneous coronary intervention (consisting of patients with symptomatic coronary artery disease including chronic coronary syndromes (CCS) and ACS) of any gender, ≥ 18 years old
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Béatrice GODEFROY | Contact | 0623822906 | +33 | beatrice.godefroy@translumina.fr |
| Name | Affiliation | Role |
|---|---|---|
| Thibault Lhermusier, Pr | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Axium | Recruiting | Aix-en-Provence | 13100 | 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 |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Procedural success rate |
|
| 7 days post-procedure |
| Assess reperfusion | Target Lesion Revascularization at 12 months | 12 months post-procedure |
| • Evaluate the antiplatelet treatment | antiplatelet consumption during 1 year after the procedure | 12 months post-procedure |
| CHU CAEN | Not yet recruiting | Caen | 14000 | France |
|
| Hôpital A. Schweitzer - GHCA | Recruiting | Colmar | 68003 | France |
|
| Clinique Louis Pasteur | Recruiting | Essey-lès-Nancy | 54271 | France |
|
| CH Haguenau | Recruiting | Haguenau | 67500 | France |
|
| CHU La Timone | Recruiting | Marseille | 13005 | France |
|
| Hopital Nord | Not yet recruiting | Marseille | 13015 | France |
|
| HP Jacques Cartier | Recruiting | Massy | 91300 | France |
|
| Clinique Pont de Chaume | Not yet recruiting | Montauban | 82000 | France |
|
| Hôpital Privé du Confluent | Recruiting | Nantes | 44277 | France |
|
| Polyclinique Les Fleurs | Recruiting | Ollioules | 83190 | France |
|
| APHP | Not yet recruiting | Paris | 75013 | France |
|
| HP Claude Galien | Not yet recruiting | Quincy-sous-Sénart | 91480 | France |
|
| CHU Reims | Recruiting | Reims | 51000 | France |
|
| Clinique Saint Hilaire | Recruiting | Rouen | 76000 | France |
|
| CHRU Strasbourg | Not yet recruiting | Strasbourg | 67091 | France |
|
| CH de Bigorre | Recruiting | Tarbes | 65013 | France |
|
| Clinique Pasteur | Not yet recruiting | Toulouse | 31076 | France |
|
| Chu Toulouse | Recruiting | Toulouse | 31400 | France |
|
| D014652 |
| Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |