Inari Medical has announced the presentation of early outcomes from the ClotTriever Outcomes Registry (CLOUT) using the ClotTriever Mechanical Thrombectomy System for treatment of acute and chronic lower extremity deep vein thrombosis (DVT).
Initial results for the first 50 patients were presented by principal investigator David J Dexter, a vascular surgeon at Sentara Healthcare in Norfolk, Virginia, USA at late-breaking clinical trials session held at 2019 Vascular InterVentional Advances conference (VIVA; 4–7 November, Las Vegas, USA).
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 is unique in that there are no exclusions for age of clot. Three-quarters of patients had clot over two weeks old and over half failed other therapies prior to treatment.
Nonetheless, thrombus was removed in all patients, and over three-quarters met the study 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 less than 30cc.
“Early results from the first 50 patients enrolled in CLOUT are encouraging with 76% of patients free from post-thrombotic syndrome (PTS) within 30 days of treatment,” said Dexter. “We may finally have the tools to truly test the hypothesis that early resolution of venous thrombus in DVT patients may prevent PTS.”
“CLOUT reflects Inari’s long-term commitment to the care of venous thromboembolism (“VTE”) patients, and to the production of clinical data to further the understanding and advance the treatment of this disease,” said Bill Hoffman, Inari’s CEO. “We remain committed to revolutionizing VTE treatment with devices that remove large clot volume from large vessels while completely eliminating lytics and their consequent cost, ICU stay, and bleeding complications.”