Inari Medical has announced planned enrollment of the DEFIANCE randomized 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 enroll 300 patients at up to 60 centers worldwide. DEFIANCE is Inari’s second RCT and it will run in parallel to the PEERLESS trial. PEERLESS commenced earlier this year and compares the 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, MD, chair of vascular surgery at MedStar Health, Washington, D.C., 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, MD, a radiologist at Beaumont Health in Dearborn, Michigan, 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.”