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To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REVA Medical ReZolve Stent | Experimental | ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReZolve Stent | Device | ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ischemia-driven Target Lesion Revascularization (TLR) | Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| QCA & IVUS derived parameters | Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume | 12 months |
| Major Adverse Coronary Events | Major Adverse Cardiac Events - Combined events consisting of death, Myocardial Infarction (Q-Wave, Non Q-wave: CPK > 2xULN + MB>ULN) (MI), and target vessel revascularization (TVR). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Abizaid, MD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese de Cardiologia | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D023903 | Coronary Restenosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| 60 months |
| Procedural and Technical Success | percentage of patients with angiographic success successful delivery and deployment of the device | Acute |