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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Angioshield
Sponsored by
Neograft Technologies, Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, Intimal Hyperplasia, Atherosclerosis, Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pope John Paul II Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device Applied

Arm Description

All participants will be treated with the Angioshield

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2014
Last Updated
January 11, 2017
Sponsor
Neograft Technologies, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02072239
Brief Title
Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neograft Technologies, Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG, Intimal Hyperplasia, Atherosclerosis, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device Applied
Arm Type
Experimental
Arm Description
All participants will be treated with the Angioshield
Intervention Type
Device
Intervention Name(s)
Angioshield
Intervention Description
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 Outcome Measure Information:
Title
MACE
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
MACE and Graft Patency
Description
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
Time Frame
30, 90 and 365 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerzy Sadowski, MD, PhD
Organizational Affiliation
Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pope John Paul II Hospital
City
Krakow
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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