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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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.
Pope John Paul II Hospital
Krakow, Poland
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.
Time frame: 30 days
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
Time frame: 30, 90 and 365 Days
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