Intravascular molecular-structural NIRF-IVUS imaging of coronary artery disease

The goal of this Phase I STTR project is to constructoptimizeand test a clinically viable intravascular
near infrared fluorescence intravascular ultrasoundNIRF IVUSimaging catheter for simultaneous
molecular and structural diagnosis of coronary artery diseaseCADCAD is a worldwide leading cause
of death and disabilityincluding acute myocardial infarctioncongestive heart failureand sudden cardiac
deathMolecular processes such as inflammation drive devastating CAD and stent complicationsbut are
largely invisible to contemporary clinical imaging methodsThe ability to image and quantify molecular
processes will greatly improve our ability to improve CAD patient risk stratificationimprove percutaneous
coronary interventionPCIprocedures at the point of careoptimally tailor CAD and stent pharmacotherapiesincluding PCSKinhibitorsand streamline new CAD and coronary stent product developmentIntravascular Imaging Inciin collaboration with MGH has developed novel and innovative intravascular
imaging systems that combine high resolution IVUSthe current anatomical imaging standard of carewith
NIRF molecular imaginga powerful new molecular imaging approachHoweverour prototype intracoronary
NIRF IVUS catheter is too largeFrenchmmfor routine clinical coronary imagingIn order to enable
clinical translational and commercialization of intracoronary NIRF imagingthis Phase I STTR objective is
designconstructand miniaturize a NIRF IVUS imaging catheter for imaging smaller coronary arteries and to
test it in vivoIn Aimiwill engineer miniaturized NIRF IVUS catheters for use in coronary arteriesandltFrenchmm diameterIn AimMGH will test the NIRF IVUS catheters in swine coronary arteries to
obtain simultaneous in vivo coronary molecular structural imaging of plaque inflammation and plaque burdenThe anticipated results of this proposal will generate a highly translatablecoronary artery NIRF IVUS imaging
catheter that can simultaneously image plaque inflammation based on NIRF molecular contrastand plaque
structure based on IVUSFollowing successful completion of this projectiwill submit an SBIR STTR Phase
II application to construct GMP grade intracoronary NIRF IVUS coronary artery imaging catheters and
systemswith the goal of obtaining FDA IDE approval for first in human studiesThe long term objective of
intracoronary NIRF IVUS is to improve the outcome of CAD patients entering the cardiac catheterization
laboratory byABetter risk stratifying patients at risk of coronary plaque or stent complicationsBIdentifying
the higher risk CAD patients likely to benefit from PCSKinhibitor therapyand CComprehensively assessing
the molecular and structural efficacy of novel CAD pharmacotherapeutics and new stents in Phase IIa IIb and
Phase III clinical trials PROJECT NARRATIVE
New methods are needed to identify patients that will suffer heart attacks and sudden cardiac death from
coronary plaque and stent complicationsThis Project willfor the first timecombine two intravascular imaging
methods based on lightnear infrared fluorescenceand soundultrasoundinto a clinically and commercially
viable catheter systemNIRF IVUSthat can simultaneously image the biology and structure of coronary artery
diseaseThe new knowledge gained from intracoronary NIRF IVUS will eventually better identify patients at
higher risk of coronary plaques and stent complicationsguide the selection of the medicines to reduce these
complicationsand provide a new approach to streamline the development of new drugs and stents designed
to treat coronary disease