Coronary Artery Disease
Conditions
Brief summary
Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.
Detailed description
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.
Interventions
DEVICEAngioshield
Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery
Sponsors
Neograft Technologies, Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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: 1. is between the ages of 18 and 80 years of age, inclusive 2. 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 3. is able to give their informed written consent 4. is willing and able to complete all follow-up visits and procedures 5. is to be treated via a medial sternotomy with cardio-pulmonary bypass during surgery 6. has adequate saphenous veins 7. Is a candidate for transcatheter therapy, PCI
Exclusion criteria
Subject will be excluded from participation in the investigation if he/she: 1. is currently enrolled in another clinical investigation 2. is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent) 3. is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months 4. history of a hypercoagulable state 5. has had an acute MI within the last 21 days 6. has had a previous CABG 7. requires emergency surgery 8. has a left ventricular ejection fraction (LVEF) less than 35 % 9. has a target vessel stenosis of less than 75% 10. has a transmural infarct of the target artery territory 11. has a serum creatinine greater than 1.5 mg/dL 12. is having concomitant -surgery of any kind 13. has had previous saphenectomy (See inclusion) 14. has saphenous vein sizes incompatible with treatment range (i.e., \<3.5 mm or \>5 mm inner diameter) 15. limb Ischemia or non-healing ulcer 16. has moderate to severe COPD defined as FEV 1 of less than 1 liter 17. has had a CVA in last 90 days 18. has diffuse disease in target vessel with an inadequate anastomotic touchdown site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety-reported MACE | 30 days | 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 |
Secondary
| Measure | 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 |
Countries
Lithuania
Outcome results
None listed