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| Name | Class |
|---|---|
| EVAMED | OTHER |
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The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients.
As routine care, each patient will be followed until 12 months after stent implantation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DES-CRE8 | Device | Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting coronary stent. The absence of the polymer minimizes the risk of inflammation/thrombosis, while the propriety formulation enhances drug absorption. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is Target Lesion Failure (TLF) rate at 1 year | The TLF is defined as cardiac deaths, heart attack in relation with the target vessel or revascularization of the target lesion. If a patient has at least one of these events, he will be considered as TLF. | 1 year post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) at 1 year | MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths. | 1 year |
| Non cardiac deaths at 1 year | Non cardiac deaths at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Participation to the study will be proposed to all diabetic patients corresponding to the inclusion and exclusion criteria after implantation of one or more coronary stent CRE8.
Patients will be consecutively included to limit selection bias.
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| Name | Affiliation | Role |
|---|---|---|
| Julien Vandenwildenberg | Alvimedica Medical France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Europe | Amiens | 80090 | France | |||
| Centre Hospitalier Avignon |
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| 1 year |
| Stent thrombosis at 1 year | Certain or probable stent thrombosis | 1 year |
| Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy | MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths. | 1 year |
| Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy | Non cardiac deaths at 1 year | 1 year |
| Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy | Certain or probable stent thrombosis | 1 year |
| Avignon |
| 84902 |
| France |
| Centre Hospitalier Beauvais | Beauvais | 60000 | France |
| Clinique Convert | Bourg-en-Bresse | 01004 | France |
| Centre Hospitalier Brive | Brive-la-Gaillarde | 19100 | France |
| Centre Hospitalier Chartres | Chartres | 280018 | France |
| Hôpital Schweitzer | Colmar | 68003 | France |
| Centre Hospitalier Sud-Francilien | Corbeil-Essonnes | 91106 | France |
| Hôpital Privé de Bourgogne | Dijon | 21000 | France |
| Hôpital Simone Veil | Eaubonne | 95602 | France |
| Clinique Pasteur | Essey-lès-Nancy | 54270 | France |
| Centre Hospitalier Gonesse | Gonesse | 95500 | France |
| Centre Hospitalier Universitaire Grenoble | Grenoble | 38043 | France |
| Centre Hospitalier Haguenau | Haguenau | 67500 | France |
| Centre Hospitalier Saint-Joseph Saint-Luc | Lyon | 69365 | France |
| Clinique Pont de Chaumes | Montauban | 82000 | France |
| Centre Hospitalier Pau | Pau | 64000 | France |
| Clinique Saint-Hilaire | Rouen | 76000 | France |
| Centre Hospitalier Saint-Quentin | Saint-Quentin | 02321 | France |
| Clinique Saint-Joseph | Trélazé | 49800 | France |
| Centre Hospitalier Valence | Valence | 26000 | France |
| Centre Hospitalier Vannes | Vannes | 56017 | France |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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