Coronary Post-Dilatation Catheter

DESCRIPTION provided by applicant Coronary artery disease CAD places a major clinical M and financial $ B by burden on the U S healthcare system The standard of care for many CAD patients with acute and stable coronary conditions involves percutaneous coronary intervention with stenting Clinical outcomes following stenting are directly related to the achievement of adequate minimal stent vascular area i e full stent deployment with full stent apposition against the vascular wall Numerous studies have shown that up to of all coronary stents are under deployed and therefore require balloon post dilatation to achieve proper stent expansion Despite post dilatation up to of stents still remain under deployed Although various factors affect stent deployment only vascular stent recoil and balloon under expansion were shown to be the major factors causing stent under expansion Balloon under expansion contributes to the majority of the stent under deployment which is not surprising given the in vivo reliance on inherently inaccurate manufacturer ex vivo pressure diameter relationships In our Phase I grant R HL Coronary Post Dilatation Catheter a novel device was described which operates as a standard coronary post dilatation catheter but also provides real time balloon dimension during inflation based on Ohmandapos s law instead of empirical pressure diameter relationships The results of the Phase I study were extremely successful for both aims The display console and CB catheter were updated in Aim and validation of the CB catheter in injured swine coronary vessels showed extremely accurate post dilatation in Aim i e in vivo CB balloon measurement accuracy bias mm which is highly acceptable clinically given this is at least an order of magnitude smaller i e x smaller than the mm standard stent divisions In this Phase II application we propose the next step of obtaining approval for an investigational device exemption IDE to conduct a human pilot study which will be used to assess primarily the device safety and secondarily device efficacy in a group of CAD patients To accomplish these Phase II objectives the following specific aims are proposed Final Animal Validation To assess the safety and efficacy of the CB catheter system in a set of diseased animals in a good laboratory practice GLP setting to be used for data submission to the FDA and institutional review boards IRBs and Human Validation To assess the safety and efficacy in a small group of humans patients in a two center study This Phase II study addresses a highly significant national and worldwide clinical need that can impact not just NHLBI but many other mission areas of NIH Successful completion of these proposed Aims will allow us to translate our research findings to a commercially available device that could drastically improve CAD patient outcomes PUBLIC HEALTH RELEVANCE Patient outcomes following coronary artery stenting are negatively impacted because of a lack of proper balloon post dilatation which is based on inaccurate pressure diameter relationships The primary objective of this Phase II SBIR is to validate the safety and efficacy of a novel post dilatation balloon catheter that uses a physical law to provide real time balloon dimension during stent expansion in a human pilot study