Coronary Artery Disease Clinical Trial
Official title:
A Phase I Open Label Pilot Study to Evaluate the Safety, Efficacy and Tolerability of Anginera for Adults With Left Ventricular Dysfunction AND Reversible Myocardial Ischemia Undergoing CABG Surgery
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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