Inari Medical Begins DEFIANCE Randomized Clinical Trial of ClotTriever System in DVT

January 12, 2023—Inari Medical, Inc. announced that the first patient has been enrolled in the DEFIANCE prospective randomized controlled trial (RCT) comparing the clinical outcomes of patients with iliofemoral deep vein thrombosis (DVT) treated with the company’s ClotTriever system versus anticoagulation only.

DEFIANCE will enroll 300 DVT patients at up to 60 centers worldwide. The plans for the trial were announced in August 2022.

The DEFIANCE trial is led by Principal Investigators Xhorlina Marko, MD; Steven Abramowitz, MD; and Professor Stephen Black, MD. Dr. Marko is an interventional radiologist at Beaumont Health in Dearborn, Michigan. Dr. Abramowitz is Chair of Vascular Surgery at MedStar Health in Washington, DC. Professor Black is a consultant vascular surgeon at Guy’s and St. Thomas’ Hospital in London, United Kingdom.

“DEFIANCE is an important step forward and will answer critical questions about how we manage DVT patients,” commented Dr. Abramowitz in the company’s press release. “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.”

The first patient in the trial was enrolled by Abdullah Shaikh, MD, Interventional Radiologist at Allegheny Health Network in Pittsburgh, Pennsylvania.

In the press release, Dr. Shaikh stated, “We’re thrilled to enroll the first patient and officially kick off this important clinical trial. ClotTriever is fundamentally different than other DVT treatments. This trial is designed to produce definitive evidence to change standard of care.”

Inari Medical noted that DEFIANCE, which is the company’s second RCT, will run in parallel to the PEERLESS trial that is comparing the FlowTriever system to catheter-directed thrombolytics in pulmonary embolism. The commencement of enrollment in PEERLESS was announced in February 2022. The FlowTriever system has received 510(k) clearance and CE Mark approval for the nonsurgical removal of clot from peripheral blood vessels, including for the use in the treatment of pulmonary embolism and clot in transit in the right atrium, advised Inari.