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

NCT02072239 | Completed DMC

• 1 other identifier: TP11-002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

CABG; Intimal Hyperplasia; Atherosclerosis; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• MACE and Graft Patency

  30, 90 and 365 Days

Study Arms (1)

Device Applied

EXPERIMENTAL

All participants will be treated with the Angioshield

Device: Angioshield

Interventions

Angioshield DEVICE

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.

Device Applied

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neograft Technologies, Incorporated: lead

Study Sites (1)

Pope John Paul II Hospital

Krakow, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jerzy Sadowski, MD, PhD

  Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 26, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: July 1, 2015
• Last Updated: January 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)