Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy
This trial is active, not recruiting.
|Condition||coronary artery disease|
|Sponsor||Neograft Technologies, Incorporated|
|Start date||February 2014|
|End date||August 2016|
|Trial size||15 participants|
|Trial identifier||NCT02072239, TP11-002|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 30 days
MACE and Graft Patency
time frame: 30, 90 and 365 Days
Male or female participants from 18 years up to 80 years old.
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
|Official title||First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery|
|Principal investigator||Jerzy Sadowski, MD, PhD|
|Description||\This is a first in human study which is intended to determine if a larger pivotal study is justified.|
Call for more information