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The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.
This registry will obtain additional safety, effectiveness, and performance data on the DynamX Coronary Bioadaptor System in the treatment of patients with ischemic heart disease due to de novo native coronary artery lesions in a real-world patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | DynamX Novolimus-eluting Coronary Bioadaptor System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DynamX Novolimus-eluting Coronary Bioadaptor System | Device | All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use |
| Measure | Description | Time Frame |
|---|---|---|
| Device Oriented Clinical Endpoint | Composite of Target Lesion Failure (TLF): cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2 | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Device Success | Achievement of a final residual stenosis <30% by QCA or visual estimation, using the study device and without a device deficiency | In-Hospital, assessed up to 7 days after procedure |
| Clinical Procedural Success |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing Percutaneous Coronary Intervention (PCI) who receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use (IFU).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Tanner | Contact | +1 408 636 2000 | ltanner@ElixirMedical.com | |
| Elizabeth Lau, PhD | Contact | elau@ElixirMedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital St. Pölten | Recruiting | Pölten | Austria |
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Achievement of a final residual stenosis <30% by QCA or visual estimation, using the study device, with or without any adjunctive devices, and without TLF
| In-Hospital, assessed up to 7 days after procedure |
| Device Oriented Clinical Endpoint | Composite of TLF: cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2 | 30 days |
| Patient Oriented Clinical Endpoint | Composite of all-cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization. | 30 days and 12 months |
| Rate of target vessel failure (TVF) | Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR). | 30 days and 12 months |
| Rate of all revascularization | Target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven. | 30 days and 12 months |
| Rate of all MI | Target and non-target vessel | 30 days and 12 months |
| Rate of all-cause death | Cardiovascular, Non-Cardiovascular, Unknown | 30 days and 12 months |
| Composite of cardiovascular death, any myocardial infarction, and any revascularization | 30 days and 12 months |
| Rate of stroke | 30 days and 12 months |
| Rate of probable or definite stent thrombosis | 30 days and 12 months |
| Duration of DAPT | 30 days and 12 months |
| Curaçao Medical Center | Recruiting | Willemstad | Curacao |
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| Heartology Cardiovascular Hospital | Recruiting | Jakarta | Indonesia |
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| Jakarta Heart Center | Recruiting | Jakarta | Indonesia |
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| Medistra Hospital | Recruiting | Jakarta | Indonesia |
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| Siloam Hospitals | Recruiting | Jakarta | Indonesia |
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| Centro Cardiologico Monzino | Recruiting | Milan | Italy |
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| Azienda Ospedaliera Universitaria "Federico II" | Recruiting | Naples | Italy |
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| Policlinico Tor Vergata | Recruiting | Rome | Italy |
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| Jordon Hospital | Recruiting | Amman | Jordan |
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| The Specialty Hospital | Recruiting | Amman | Jordan |
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| King Fahad Armed Forces Hospital | Recruiting | Jeddah | Saudi Arabia |
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| Istanbul Medipol Mega University Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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| Memorial Bahçelievler Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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| Al Qassimi Hospital | Recruiting | Sharjah city | United Arab Emirates |
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| Tam Duc Heart Hospital | Recruiting | Ho Chi Minh City | Vietnam |
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| Kiến Giang General Hospital | Recruiting | Kiến Giang | Vietnam |
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| 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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