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

NCT ID: NCT02072239

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-07-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Applied

All participants will be treated with the Angioshield

Group Type: EXPERIMENTAL

Angioshield

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neograft Technologies, Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerzy Sadowski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland

Locations

Pope John Paul II Hospital

Krakow, , Poland

Countries

Poland

Other Identifiers

TP11-002

Identifier Type: -

Identifier Source: org_study_id