Inari Medical has announced the enrolment of the first patient in the DEFIANCE trial which will evaluate the clinical results of patients with iliofemoral deep vein thrombosis (DVT) treated with the firm’s ClotTriever System in comparison to treatment with anticoagulation only.
DEFIANCE is a prospective randomised controlled trial (RCT) which will feature 300 DVT patients at up to 60 centres globally. The plans for the trial were disclosed in August last year.
The ClotTriever is an over-the-wire system intended to mechanically core clot from the vein wall and capture and remove large clot burden from big vessels.
Inari Medical chief medical officer Thomas Tu said: “With six major clinical studies, including two ongoing RCTs, Inari is wholly committed to VTE patients and producing definitive evidence to support our technologies.
“None of this is possible without the collaboration and dedication of our clinical trial investigators who continually push the field forward in the name of better patient outcomes.”
Dr. Abdullah Shaikh, an interventional radiologist at Allegheny Health Network in Pittsburgh, Pennsylvania, enrolled the first patient in the DEFIANCE trial.
Shaikh said: “We’re thrilled to enrol 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.”
According to the US-based medical device company, the DEFIANCE trial is its second RCT. It will be enrolling parallel to the PEERLESS trial that is comparing the FlowTriever system to catheter-directed thrombolytics in patients having intermediate-high risk pulmonary embolism.
PEERLESS enrolment began in February 2022. The FlowTriever system had previously secured CE Mark and US Food and Drug Administration (FDA) 510(k) clearance for the treatment of pulmonary embolism and right atrial clot in transit (CIT).
