Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery
Santariskiu University Hospital
Vilnius, Lithuania
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
Time frame: 30 days
Safety, (MACE) will be assessed by recording and reporting of adverse events at the 30, 90, and 365 day follow-up visits.
Time frame: 90 and 365 days
Patency: Graft patency (via serial CT angiograms) will be measured at the 30, 90, and 365 day follow-up visits.
Time frame: 30, 90 ,and 365 days
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