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Clinical Trial Summary

This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.


Clinical Trial Description

A prospective, multicenter, open-label Phase I safety study of Anginera. Adults with Left Ventricular Dysfunction and reversible myocardial ischemia who are undergoing a CABG procedure, who have at least one graftable vessel and at least one coronary vessel not amenable to bypass or PCI (Percutaneous Coronary Intervention)will be recruited. Three pieces of Anginera will be placed on the area of the surface of the ventricle, including the area supplied by the vessel or vessels that cannot be bypassed, as well as surrounding myocardium. Patients will be followed for 12 months after the surgery at which Anginera is implanted.

The primary objective is to determine safety. The secondary objectives are to determine regional myocardial perfusion and regional left ventricular performance and to investigate the utility of measures of patient perception of improvement. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00364390
Study type Interventional
Source Theregen, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 2006
Completion date February 2009

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