The PEERLESS II is the company’s third randomised controlled trial in venous thromboembolism. Credit: Bencemor / Shutterstock.com.

Inari Medical has unveiled planned recruitment for its third randomised controlled trial (RCT) in venous thromboembolism (VTE) for the evaluation of its FlowTriever system.

The company has revealed the trial design for the PEERLESS II study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2023 Scientific Sessions in Phoenix, Arizona, US.

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Inari chief medical officer Dr Thomas Tu said: “With over 1,700 patients across PEERLESS and PEERLESS II, Inari is now set to enrol more PE RCT patients than all industry and non-industry RCTs combined.

“Inari’s three RCTs in VTE all aim to study meaningful, patient-centric clinical endpoints. We are thankful for the partnership of our Steering Committee and the commitment of our investigators dedicated to generating high-quality clinical evidence.”

PEERLESS II is a multi-centre, prospective, global RCT designed to compare the clinical outcomes of the FlowTriever system versus anticoagulation alone in intermediate-risk pulmonary embolism (PE) patients.

The company will recruit up to 1,200 patients who will be studied during the trial, which is planned to take place at up to 100 centres across the world.

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Global principal investigators Dr Jay Giri, Dr Frances Mae West, Professor Bernhard Gebauer and Professor Felix Mahfoud will lead the study.

In a statement, Dr Giri said: “PEERLESS II is a ground-breaking trial in terms of its robust size, randomised design and potential to shape PE treatment guidelines.

“The primary outcome for the trial is a hierarchical composite of clinical outcomes including mortality, clinical deterioration, hospital re-admission and dyspnea.

“These meaningful endpoints go beyond historical surrogate measures such as RV/LV ratio to definitively answer critical questions about intervention in PE with the FlowTriever system.”