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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Neograft Technologies, Incorporated
Sponsor:
Information provided by (Responsible Party):
Neograft Technologies, Incorporated
ClinicalTrials.gov Identifier:
NCT02072239
First received: February 13, 2014
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 Intervention
Coronary Artery Disease
Device: Angioshield

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Neograft Technologies, Incorporated:

Primary Outcome Measures:
  • MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30, 90 and 365 Days ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 15
Study Start Date: February 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072239

Locations
Poland
Pope John Paul II Hospital Recruiting
Krakow, Poland
Contact: Jerzy Sadowski, MD, PhD    48 12 614 30 75      
Sub-Investigator: Bogusław Kapelak, MD         
Sub-Investigator: Krzysztof Bartus, Md, PhD         
Sponsors and Collaborators
Neograft Technologies, Incorporated
Investigators
Principal Investigator: Jerzy Sadowski, MD, PhD Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland
  More Information

No publications provided

Responsible Party: Neograft Technologies, Incorporated
ClinicalTrials.gov Identifier: NCT02072239     History of Changes
Other Study ID Numbers: TP11-002
Study First Received: February 13, 2014
Last Updated: February 24, 2014
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

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

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

ClinicalTrials.gov processed this record on September 18, 2014