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| Name | Class |
|---|---|
| Istituto Clinico Humanitas | OTHER |
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The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DynamX Drug-Eluting Coronary Bioadaptor System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DynamX Drug-Eluting Coronary Bioadaptor System | Device | DynamX Drug-Eluting Coronary Bioadaptor System Implantation in Coronary Artery Lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean in-device lumen area and mean device area | Change in mean in-device lumen area and mean device area, as measured by Optical coherence tomography (OCT) | Through 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Event (MACE) | Major adverse cardiac event (MACE) (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) | 9 months, 12 months and 24 months |
| Cardiac Death (CD) |
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Inclusion Criteria:
Presence of complex coronary lesions defined as follows:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Rozzano | Italy |
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All imaging analyses will be performed at an independent core laboratory (Cardiovascular Department, San Giovanni Addolorata Hospital, Rome, Italy) by experienced operators blinded to procedural data and clinical outcomes.
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Cardiac Death (CD)
| 9 months, 12 months and 24 months |
| Myocardial Infarction (MI) | Myocardial Infarction (MI) | 9 months, 12 months and 24 months |
| Target Lesion Revascularization (TLR) | Target Lesion Revascularization (TLR) | 9 months, 12 months and 24 months |
| Stent Thrombosis (ST) | Stent Thrombosis (ST) | 9 months, 12 months and 24 months |
| Stent Cross-Sectional Area | Stent Cross-Sectional Area by OCT | 9 months |
| Minimum stent diameter | Minimum stent diameter by OCT | 9 months |
| Maximum stent diameter | Maximum stent diameter by OCT | 9 months |
| Intimal hyperplasia (IH) area | Intimal hyperplasia (IH) area (calculated as stent area minus luminal area) by OCT | 9 months |
| Percentage of intimal hyperplasia | Percentage of intimal hyperplasia (IH area divided by stent area) by OCT | 9 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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