The Angioshield Study Feasibility II

Status Completed

Clinical Trial Summary

Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.

Clinical Trial Description

The study is designed to investigate the feasibility of using an applied support (Angioshield) to a saphenous vein to be used in Coronary Artery Bypass Surgery. It is a feasibility to determine safety prior to launching a larger pivotal study. The primary endpoint, 30-day safety, will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit. The secondary endpoints, long term safety and patency, will be assessed by recording and reporting of adverse events and graft patency (via serial CT angiograms) at the 30, 90, and 365 day follow-up visits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02543047
Study type	Interventional
Source	Neograft Technologies, Incorporated
Contact
Status	Completed
Phase	N/A
Start date	November 2015
Completion date	March 7, 2018

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