Inari Medical has enrolled the first participant in the DEFIANCE trial of its ClotTriever System in iliofemoral deep vein thrombosis (DVT) patients.
Allegheny Health Network interventional radiologist Dr Abdullah Shaikh has enrolled the first participant in the trial in Pittsburgh, Pennsylvania, US.
The prospective randomised controlled trial (RCT) has been designed to compare the clinical results of DVT patients treated with the ClotTriever System versus treatment with anticoagulation only.
Up to 300 DVT patients are expected to be enrolled at up to 60 centres across the world.
Inari Medical chief medical officer Dr 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.”
The ClotTriever is an over-the-wire system that is designed to capture and remove large clot burdens from big vessels.
It is developed to eliminate the need for thrombolytics and avoid capital equipment.
The company stated that the DEFIANCE trial is its second RCT and it will be enrolling participants in the PEERLESS pulmonary embolism trial simultaneously.
MedStar Health Vascular Surgery chair Dr Steven Abramowitz said: “DEFIANCE is an important step forward and will answer critical questions about how we manage DVT patients.
“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.”