Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy

Study Overview
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Brief Summary
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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.

Detailed Description
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\This is a first in human study which is intended to determine if a larger pivotal study is justified.

Official Title
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First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Angioshield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject will be eligible for inclusion in the investigation if he/she: is between the ages of 18 and 80 years of age, inclusive requires Coronary Atery Bypass Graft (CABG) surgery with minimum of one SVG used to bypass a stenosis in the Right Coronary, the Circumflex, a Diagonal, or an Obtuse Marginal artery, due to atherosclerotic coronary artery disease is able to give their informed written consent is willing and able to complete all follow-up visits and procedures Exclusion Criteria: Subject will be excluded from participation in the investigation if he/she: is currently enrolled in another clinical investigation is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent) is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months shows a presence of hypercoagulable state or history of idiopathic venous or arterial thrombosis has had an acute MI within the last 21 days has had a previous CABG requires emergency surgery has a left ejection fraction (LEF) less than 20% has a target vessel stenosis of less than 70% has a transmural infarct of the target artery territory currently requiring dialysis is having concomitant-surgery of any kind has varicose veins has had previous saphenectomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Applied<br>All participants will be treated with the Angioshield | Device: Angioshield<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 30, 90 and 365 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Intimal Hyperplasia, Atherosclerosis, Myocardial Infarction