Inari Medical said it has enrolled the first patient in the ClotTriever Outcomes Registry (“CLOUT”) using its ClotTriever thrombectomy system.
The ClotTriever device is designed to remove blood clots from large vessels in the peripheral vasculature via access sites as small as 6 mm.
CLOUT is a 500-patient prospective, multicenter, single-arm registry to evaluate real-world outcomes after treatment of patients with thrombosis in the deep veins of the lower extremity with ClotTriever. Dr. William Marston, chief of vascular surgery at the University of North Carolina, and Dr. Robert Beasley, section chief of vascular and interventional radiology at Mount Sinai Medical Center, are co-principal investigators.
“ClotTriever is an important new tool for venous thrombus,” Marston in a prepared statement. “The acute outcomes measures will allow us to evaluate the safety profile of ClotTriever as a single-session, non-thrombolytic option. The two-year follow-up will allow us to determine if significant clot removal improves symptoms and outcomes over the longer term.”
“We are pleased to be the first site to enroll a patient in the CLOUT registry,” added Dr. Herman Kado, medical director of cardiology at St. John Oakland Hospital. “In our experience, the ClotTriever System consistently and efficiently removes iliofemoral clot, allowing us to complete treatment in a single session without the need for thrombolytic drugs or the consequent ICU stay. We’re excited to help evaluate outcomes in a formal study.”
ClotTriever does not require the use of thrombolytic drugs, which carry a significant risk of bleeding and are contraindicated in many patients. The FDA granted it pre-market approval in 2017. Irvine, Calif.-based Inari also makes the FlowTriever device, which is designed to retrieve pulmonary embolisms.