STTR Phase I: A Resorbable Luminal Barrier to Treat Peripheral Artery Disease

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project addresses the estimated 8 million people in the US with peripheral artery disease (PAD). The population of PAD is increasing due to the aging population, high prevalence of obesity and diabetes, and improved diagnosis of the disease. Patients with PAD suffer from pain, ischemia, and infection in their lower limbs, and cost the healthcare system an estimated $6000 in direct spending per patient annually. The current and emerging technologies to treat PAD are ineffective in patients with long, diffuse lesions, calcified plaques, or patients with kidney disease. Further, the standard practice of using cytostatic agents and antiplatelet drugs adds additional risk to the patient and cost to the healthcare system. There is therefore great need to develop new, effective, and safe therapies for use in vascular interventions, including balloon angioplasty, stenting, or atherectomy. New therapies should be robust enough to be effective in a wide range of interventions and patient populations and address the specific injury that is caused to the vessel during the intervention. The proposed project examines the therapeutic use of a new material in vascular interventions with robust application and that specifically targets the initiating injury. This new material is delivered to the vessel wall at the site of injury, where it binds and prevents the cascading inflammatory response that leads to scarring of the vessel. Additionally, the new therapeutic is expected to promote re-endothelialization of the vessel wall, so that the injury site is rapidly healed. This proposal will examine how the therapeutic is delivered to the vessel wall following injury, how long it remains on the vessel wall, and if it can promote the vessel healing so that the neo-intimal hyperplasia does not form. A rabbit animal will be used, and balloon angioplasty will be performed, followed by delivery of the new therapeutic. Visualization of the therapeutic, platelets, and endothelial cells will take place from 2 hours to 7 days to determine the interaction of the components during the healing process. It is expected that the therapeutic will remain at the site of injury and prevent undesirable platelet binding until healing of the vessel occurs through re-endothelialization. By protecting the injured site, it can be demonstrated that vessel scarring is prevented.