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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Angioshield

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland
    • Pope John Paul II Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Applied; All participants will be treated with the Angioshield	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE and Graft Patency	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	30, 90 and 365 Days

Collaborators and Investigators

• Sponsor: Neograft Technologies, Incorporated
• Investigators: Principal Investigator: Jerzy Sadowski, MD, PhD, Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Atherosclerosis; CABG; Myocardial Infarction; Intimal Hyperplasia
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: TP11-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No