November 6, 2019—Inari Medical, Inc. announced the presentation of early outcomes from CLOUT, the ClotTriever Outcomes Registry evaluating the company’s ClotTriever mechanical thrombectomy system for treatment of acute and chronic lower extremity deep vein thrombosis (DVT).
The initial results for the first 50 patients in the registry were presented by Principal Investigator David J. Dexter, MD, in a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
Inari’s ClotTriever system is designed to remove large clot volume from large veins. The procedure does not require use of thrombolytic drugs. The ClotTriever system received FDA 510(k) clearance for the nonsurgical removal of thrombus from the peripheral vasculature.
According to the company, CLOUT is a 500-patient prospective, multicenter, single-arm registry evaluating real-world patient outcomes after treatment of lower extremity DVT with ClotTriever. The study has no exclusions for age of clot. Three-quarters of patients presented with clot > 2 weeks old. More than half of patients failed other therapies before treatment.
Investigators removed thrombus in all patients, and more than three-quarters of patients met the study's primary effectiveness endpoint of near-complete clot resolution. No patients received thrombolytics, no bleeding complications were reported, and no procedure- or device-related major adverse events were reported. Average blood loss was < 30 mL.
Dr. Dexter commented in Inari’s announcement, "Early results from the first 50 patients enrolled in CLOUT are encouraging with 76% of patients free from postthrombotic syndrome (PTS) within 30 days of treatment. We may finally have the tools to truly test the hypothesis that early resolution of venous thrombus in DVT patients may prevent PTS."