Inari Medical has announced planned enrolment of the DEFIANCE randomised controlled trial (RCT), which is designed to compare the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only.
The trial will enrol 300 patients at up to 60 centres worldwide. DEFIANCE is Inari’s second RCT and it will run in parallel to the PEERLESS trial. PEERLESS commenced earlier this year and compares FlowTriever to catheter-directed thrombolytics in pulmonary embolism.
“Anticoagulation is still the predominant therapy used in the management of DVT and in some studies has been associated with post-thrombotic syndrome (PTS) in up to 50% of patients,” said Steven Abramowitz (MedStar Health, Washington, DC, USA), co-principal investigator. “PTS is a debilitating condition with symptoms including swelling, difficulty walking, skin changes and poorly healing open wounds. Research has shown PTS quality of life scores can be as low as those of patients suffering from heart failure or cancer. Mechanical thrombectomy procedures, using technology like ClotTriever, rapidly remove large volumes of DVT and may thereby reduce the risk of PTS.”
“DEFIANCE is the first RCT to compare mechanical thrombectomy to anticoagulation for the treatment of DVT,” said Xhorlina Marko (Beaumont Health, Dearborn, USA), co-principal investigator. “The primary endpoint for the trial is a hierarchical composite of treatment failure and PTS severity at six months. The trial has the potential to influence guidelines and change the standard of care.”
“Physicians need to know in which patients to use our devices and what outcomes to expect. This is our basic responsibility,” said Thomas Tu, Inari’s chief medical officer. “We have studied over 2,000 patients, published 250 peer reviewed publications, and DEFIANCE marks our sixth major clinical study. These high-quality studies will establish a new standard of care for patients and further distance us from competition.”