Peripheral Artery Thrombosis Clinical Trial
Official title:
JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study
The JETi Hong Kong PMS is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the lower extremity peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days after the JETi procedure.
The JETi System is a hydro-mechanical aspiration system manufactured by Abbott Medical, consisting of a catheter, pump set, and accessories. The system is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion. This study will collect data on how the JETi System performs in the treatment of patients undergoing a percutaneous thrombectomy procedure for peripheral arterial or venous thrombosis of the lower extremity. Each participating investigator will determine and implement the best treatment strategy for their patients based on the clinical situation and local physician practices. All investigators involved in the conduct of the study will be qualified by education, training, and experience to perform their tasks. ;