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

Neograft Technologies

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Angioshield

Study type: Interventional

Funder types: Industry

Identifiers

NCT02072239

TP11-002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Device Applied

Experimental group

Description:

All participants will be treated with the Angioshield

Treatment:

Device: Angioshield