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The purpose of this study is to determine whether or not the Angioshield device can be safely applied to support saphenous vein grafts used in standard coronary bypass surgery.
\This is a first in human study which is intended to determine if a larger pivotal study is justified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Applied | Experimental | All participants will be treated with the Angioshield |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angioshield | Device | The Angioshield wrap provides external structural support for the saphenous vein graft used in CABG surgery and is intended to prevent over distention of the graft under arterial pressure, potentially improving graft patency and reducing the likelihood of graft failure. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | The primary objective of this study is to provide acute and subacute (up to 30 days) safety outcomes to support expansion to a pivotal study involving a larger subject population. All Major Adverse Cardiac Events (MACE), defined as the composite of cardiac death, myocardial infarction (Q-wave and non-Q wave), and target vessel revascularization, will be evaluated at 30 days post-operative. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| MACE and Graft Patency | The secondary objective of this study is to assess long term (up to 1 year) safety outcomes and vein patency for additional safety and preliminary efficacy information. All MACE, defined as the composite of cardiac death, myocardial infarction (Q-wave and non-Q wave), and target vessel revascularization will be evaluated at 90 and 365 days and to assess patency of the treated saphenous vein graft at 30, 90 and 365 days |
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Inclusion Criteria:
Subject will be eligible for inclusion in the investigation if he/she:
Exclusion Criteria:
Subject will be excluded from participation in the investigation if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Jerzy Sadowski, MD, PhD | Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pope John Paul II Hospital | Krakow | Poland |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 30, 90 and 365 Days |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |