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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072239
• Other study ID #: TP11-002
• Status: Completed
• Phase: N/A
• First received: February 13, 2014
• Last updated: January 11, 2017
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Neograft Technologies, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: July 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Poland	Pope John Paul II Hospital	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Neograft Technologies, Incorporated

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes