Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment angioshield
Sponsor Neograft Technologies, Incorporated
Start date February 2014
End date August 2016
Trial size 15 participants
Trial identifier NCT02072239, TP11-002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All participants will be treated with the Angioshield
angioshield
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.

Primary Outcomes

Measure
MACE
time frame: 30 days

Secondary Outcomes

Measure
MACE and Graft Patency
time frame: 30, 90 and 365 Days

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Neograft Technologies, Incorporated.