Inari Medical announced that the first patient has been enrolled in DEFIANCE, a prospective randomized controlled trial (RCT) comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the ClotTriever system versus anticoagulation only.
The trial is led by principal investigators Xhorlina Marko, MD, from Beaumont Health in Dearborn, Michigan, Steven Abramowitz, MD, from MedStar Health in Washington, D.C., and Stephen Black, MD, from Guy’s and St Thomas’ Hospital in London, England.
The first DEFIANCE patient was enrolled by Abdullah Shaikh, MD, from Allegheny Health Network in Pittsburgh. DEFIANCE will enroll 300 DVT patients at up to 60 centers worldwide. DEFIANCE is Inari Medical’s second RCT, enrolling in parallel to the PEERLESS pulmonary embolism trial.
“We are thrilled to enroll the first patient and officially kick off this important clinical trial,” said Shaikh. “ClotTriever is fundamentally different to other DVT treatments. This trial is designed to produce definitive evidence to change standard of care.”
“DEFIANCE is an important step forward and will answer critical questions about how we manage DVT patients,” said Abramowitz. “Prior RCTs have focused on thrombolytic-based interventions, which have known downsides and limited effectiveness. This ClotTriever RCT is the first to compare lytic-free thrombectomy to anticoagulation for DVT.”
