Software for OCT Analysis of Vascular Stents PI: Ronny Shalev, PhD, Dyad Medical Summary Dyad Medical, Inc. will create intravascular OCT (IVOCT) software for clinical, live time determination of stent apposition (OCTivat-live, the live time OCT image visualization and analysis tool) and for offline analysis of stent implantation (OCTivat-stent). Every year, 100s of thousands of patients in the US are treated with intra- vascular stents creating an opportunity for both solutions. Although advancements such as drug eluting metal stents hinder restenosis, there remains significant room for improvement. Stent design parameters include drug, material (bioresorbable vs metal), polymer composition, coatings to stimulate cell coverage, etc. To opti- mize designs, sensitive, in vivo assessments are needed for preclinical and clinical evaluations. Intravascular OCT (IVOCT) is the lone imaging modality with the resolution and contrast to meet this challenge. The Core Lab at CWRU is the premiere site in the world for manual analysis of IVOCT image data. A cardiologist analyst takes 6-16 hrs to analyze manually a single stent, and despite training and quality assurance measures, inter- analyst variability can limit the power to determine changes between stent designs. Building upon work at CWRU, we will develop advanced, highly automated software to greatly speed analysis, improve reproducibil- ity, increase accuracy, and harmonize analysis. Software will reduce costs by decreasing manual labor, and with improved reproducibility, possibly enable the use of historical data, eliminating cost of a control arm. Re- garding live time analysis, rather than manually reviewing >500 images in a pullback, with fast software, it will be possible to present the number and location of malapposed struts in 3D, providing instant feedback to phy- sicians on the need for additional dilatation with a larger balloon or higher pressure. In addition, we will auto- matically determine stent and vessel area along the length of the pullback, allowing us to compute stent ex- pansion and eccentricity, quantitative measures related to successful stent deployment, the most important de- terminant of outcome. IVOCT could also play a role at patient follow up. If a stent is well covered, then long- term anti-platelet therapy might be unnecessary, minimizing bleeding risk. If a stent has many uncovered struts, a therapeutic might prevent stent thrombosis or stimulate healing.
We will develop methods for improved in vivo assessment of intravascular stents, the treatment of choice for 100s of thousands of patients, suffering from ischemic heart disease, in the US every year. Our methods will enable optimization of stent technologies and improved deployment for improved treatment of vascular dis- ease.
