As our insatiable quest for knowledge and the passion to help people continues to grow, director of Sydney Medical Interventions, Dr Albert Goh is excited to be the principal investigator at the RNSH for the SHIELD Clinical Trial (Study in Humans to Investigate the Efficacy and Safety of Luminal SBCV Delivery in Peripheral Artery Disease).
As a consequence of any vascular procedure, whether surgical or interventional, the extracellular matrix (ECM), which activates a flow of inflammatory responses, can lead to thrombosis and the formation of scar tissue inside the vessel (neointimal hyperplasia) resulting in re-stenosis/re-narrowing. The current methodology to prevent the formation of scar tissue is to administer antiproliferative drugs during vascular procedures, potentially hindering the healing of the injured site and resulting in risk of prolonged systemic antiplatelet therapy.
This First in Man study, will evaluate the safety and efficacy of a locally applied, single‐use treatment for the reduction of neointimal hyperplasia resulting from the vascular injury following percutaneous transluminal angioplasty (PTA). This is hoped to improve healing and to prevent re-narrowing of the vessel.
This multicentre, parallel, blinded, randomised clinical trial will enrol approximately 66 patients at multiple sites in Australia and New Zealand, and compare the safety and efficacy of balloon angioplasty with or without the addition of the agent in peripheral artery disease (PAD) patients undergoing procedures for stenosis or occlusion within the superficial femoral artery (SFA).