Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Angioshield

• Registration Number: NCT02072239
• Lead Sponsor: Neograft Technologies, Incorporated

Brief 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.

Detailed Description

\\This is a first in human study which is intended to determine if a larger pivotal study is justified.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Primary Completion: 2014-09
• Study Completion: 2015-07
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Applied	Angioshield	All participants will be treated with the Angioshield

Primary Outcome Measures

Name	Time	Method
MACE	30 days	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.

Secondary Outcome Measures

Name	Time	Method
MACE and Graft Patency	30, 90 and 365 Days	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

Trial Locations

Locations (1)

Pope John Paul II Hospital; 🇵🇱 Krakow, Poland