CLOUT Registry Begins Enrollment for Inari's ClotTriever Thrombectomy System

September 27, 2018—Inari Medical, Inc. announced the enrollment of the first patient in the ClotTriever Outcomes Registry CLOUT using the company's ClotTriever thrombectomy system.

According to the company, CLOUT is a 500-patient prospective, multicenter, single-arm registry that will evaluate real-world outcomes after using ClotTriever to treat patients with thrombosis in the deep veins of the lower extremities. William Marston, MD, and Robert Beasley, MD, are coprincipal investigators of the registry.

In the Inari announcement, Dr. Marston commented, “ClotTriever is an important new tool for venous thrombus. The acute outcomes measures will allow us to evaluate the safety profile of ClotTriever as a single session nonthrombolytic option. The 2-year follow-up will allow us to determine if significant clot removal improves symptoms and outcomes over the longer term.”

Herman Kado, MD, stated, “We are pleased to be the first site to enroll a patient in the CLOUT registry. 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 intensive care unit stay. We’re excited to help evaluate outcomes in a formal study.”

The ClotTriever system is designed to remove large clot volume from large veins via access sites as small as 6 mm without requiring the use of thrombolytic drugs. The ClotTriever thrombectomy system is 510(k) cleared by the FDA for the nonsurgical removal of thrombus from the peripheral vasculature, advised Inari Medical.