Inari Medical (Nasdaq:NARI) announced that it will conduct a trial for its ClotTriever system for iliofemoral deep vein thrombosis (DVT).
The Irvine, California-based company’s Defiance trial will compare ClotTriever to anticoagulation only for patients with iliofemoral DVT.
Defiance will enroll 300 patients across up to 60 centers around the world. It represents Inari’s second randomized controlled trial, running in parallel to the Peerless trial. Peerless compares the FlowTriever to catheter-directed thrombolytics in pulmonary embolism.
According to an Inari news release, the primary endpoint is a hierarchical composite of treatment failure and PTS severity at 6 months.
Dr. Xhorlina Marko, co-principal investigator and interventional radiologist at Beaumont Health, said in the release that Defiance is the first randomized controlled trial that compares mechanical thrombectomy to anticoagulation for the treatment of DVT.
Dr. Steven Abramowitz, co-principal investigator and chair of vascular surgery at MedStar Health, said ClotTriever rapidly removes large volumes of DVT and could reduce the risk of post-thrombotic syndrome (PTS). PTS can cause swelling, difficulty walking, skin changes and poorly healing open wounds.
“Physicians need to know in which patients to use our devices and what outcomes to expect. This is our basic responsibility,” said Dr. Thomas Tu, Inari CMO. “We have studied over 2,000 patients, published 250 peer-reviewed publications, and DEFIANCE marks our 6th major clinical study. These high-quality studies will establish a new standard of care for patients and further distance us from competition.”