Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy
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.
|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|
- 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.
- 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
|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)|
Experimental: Device Applied
All participants will be treated with the 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.
\This is a first in human study which is intended to determine if a larger pivotal study is justified.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02072239
|Pope John Paul II Hospital||Recruiting|
|Contact: Jerzy Sadowski, MD, PhD 48 12 614 30 75|
|Sub-Investigator: Bogusław Kapelak, MD|
|Sub-Investigator: Krzysztof Bartus, Md, PhD|
|Principal Investigator:||Jerzy Sadowski, MD, PhD||Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland|