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| Name | Class |
|---|---|
| CERES GmbH | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of the eucaLimus Sirolimus Eluting stent system in patients with de novo coronary lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eucaLimus | Experimental | Percutaneous Coronary Intervention (PCI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eucaLimus | Device | Percutaneous Coronary Intervention (PCI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lumen Revascularisation (TLR) | Clinical driven TLR | 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lumen Revascularisation (TLR) | Clinical driven TLR | 1 month, 6 months, 24 months post procedure |
| Composite of cardiac death | MI attributed to the target vessel and clinically driven target lesion revascularization |
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Inclusion Criteria:
Each target lesion/vessel must meet all of the following angiographic criteria for the subject to be eligible for the trial:
Exclusion Criteria:
Subjects will be excluded from the trial if any of the target lesions/vessels meets any of the following angiographic criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Giese, Dr. | Contact | +49 7623 7177 | 103 | clinicaltrial@eucatech.de |
| Alexander Karl, Dipl.-Ing. | Contact | +49 7623 7177 | 140 | clinicaltrial@eucatech.de |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc Pernes, Dr. | Hôpital privé d' Antony 1 rue Velpeau 92160 Antony, France | Principal Investigator |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 month, 6 months, 12 months, 24 months post procedure |
| Composite of all-cause mortality | any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels | 24 months post procedure |
| Stent thrombosis | 1 month, 6 months, 12 months, 24 months post procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |