Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy
|ClinicalTrials.gov Identifier: NCT02072239|
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Angioshield||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||July 2015|
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.
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT02072239
|Pope John Paul II Hospital|
|Principal Investigator:||Jerzy Sadowski, MD, PhD||Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland|