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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02072239
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : January 13, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Coronary Artery Disease 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  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Primary Completion Date : September 2014
Study Completion Date : July 2015

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.

Primary Outcome Measures :
  1. MACE [ Time Frame: 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 :
  1. MACE and Graft Patency [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02072239

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

Responsible Party: Neograft Technologies, Incorporated Identifier: NCT02072239     History of Changes
Other Study ID Numbers: TP11-002
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Neograft Technologies, Incorporated:
Intimal Hyperplasia
Myocardial Infarction

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases