The Angioshield Study Feasibility II

Study Overview
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Brief Summary
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Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.

Detailed Description
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The study is designed to investigate the feasibility of using an applied support (Angioshield) to a saphenous vein to be used in Coronary Artery Bypass Surgery. It is a feasibility to determine safety prior to launching a larger pivotal study. The primary endpoint, 30-day safety, will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit. The secondary endpoints, long term safety and patency, will be assessed by recording and reporting of adverse events and graft patency (via serial CT angiograms) at the 30, 90, and 365 day follow-up visits.

Official Title
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THE ANGIOSHIELD STUDY:Feasibility Study to Demonstrate the Safety 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 CABG surgery due to atherosclerotic coronary artery disease with minimum of two SVGs, one used to bypass a stenosis in the main Right Coronary artery and one used to bypass a stenosis in the Circumflex artery territory is able to give their informed written consent is willing and able to complete all follow-up visits and procedures is to be treated via a medial sternotomy with cardio-pulmonary bypass during surgery has adequate saphenous veins Is a candidate for transcatheter therapy, PCI 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 history of a hypercoagulable state has had an acute MI within the last 21 days has had a previous CABG requires emergency surgery has a left ventricular ejection fraction (LVEF) less than 35 % has a target vessel stenosis of less than 75% has a transmural infarct of the target artery territory has a serum creatinine greater than 1.5 mg/dL is having concomitant -surgery of any kind has had previous saphenectomy (See inclusion) has saphenous vein sizes incompatible with treatment range (i.e., <3.5 mm or >5 mm inner diameter) limb Ischemia or non-healing ulcer has moderate to severe COPD defined as FEV 1 of less than 1 liter has had a CVA in last 90 days has diffuse disease in target vessel with an inadequate anastomotic touchdown site

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Right Region<br>Angioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the right region of the heart | Device: Angioshield<br>* Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery<br>|
| Active Comparator: Left Region<br>Angioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the left region of the heart | Device: Angioshield<br>* Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety-reported MACE | The primary endpoint, 30 day safety, (MACE) will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, (MACE) will be assessed by recording and reporting of adverse events at the 30, 90, and 365 day follow-up visits. |  | 90 and 365 days | 
| Patency: Graft patency (via serial CT angiograms) will be measured at the 30, 90, and 365 day follow-up visits. |  | 30, 90 ,and 365 days |