Coronary Artery Disease
Conditions
Keywords
CABG, Intimal Hyperplasia, Atherosclerosis, Myocardial Infarction
Brief summary
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
\\This is a first in human study which is intended to determine if a larger pivotal study is justified.
Interventions
DEVICEAngioshield
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.
Sponsors
Neograft Technologies, Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MACE and Graft Patency | 30, 90 and 365 Days | 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 |
Countries
Poland
Outcome results
None listed