Date of Award
Master of Science (MS)
Peripheral artery disease (PAD) is a disease that affects over 200 million patients worldwide and results in a narrowing of the blood vessels in the lower limbs that is caused by plaque buildup and chronic inflammation. The standard of care for treating this disease is the use of a drug-coated balloon (DCB) to open up the artery through the dilation of the vessel with the balloon and to deliver paclitaxel which prevents the vessel from narrowing after the procedure. In the United States, these DCBs are only approved by the FDA to be used in the artery segments above the knee. No DCB has been approved for use in the smaller arteries that are found below the knee, despite there being almost 80,000 procedures each year that could use a DCB. Instead, these vessels are treated using a plain balloon angioplasty which has a 50% likelihood of requiring a follow-up procedure to reopen the vessel after one year. It has been hypothesized that particulates shed from DCBs lead to worse outcomes when they are deployed in the arteries below the knee, which has prevented their commercial use. The purpose of this thesis was to conduct experiments on a prototype DCB that is targeting the below the knee artery segments. The data from these experiments could help to support the initiation of a clinical trial for the prototype device by providing physiologically relevant data that supports the safety of this device. The data of interest for this study was the size and number of particles that were generated from the DCB and how it compared against the DCBs currently FDA approved for use above the knee. Also of interest was the amount of drug that was delivered to the vessel and the amount of drug released into the blood. Together, these data could support the hypothesis that this prototype DCB generates fewer and smaller particles that rapidly dissolve in blood. If confirmed, this device could present a lower risk of vessel occlusion or thrombus formation when used to treat PAD in vessels below the knee.
Biomedical Engineering and Bioengineering
Below the knee, DCB, Drug Coated Balloon, Flow Model, Particles, Peripheral Artery Disease
Number of Pages
University of South Dakota
Rykhus, Ryan, "COMPARISON OF PARTICULATE LOAD & CHARACTERIZATION IN DRUG COATED BALLOONS" (2022). Dissertations and Theses. 67.
Available for download on Thursday, August 29, 2024