PERSEVERE

• Research type

  Research Study

• Full title

  Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

• IRAS ID

  332353

• Contact name

  Tushar Kotecha

• Contact email

  tushar.kotecha@nhs.net

• Sponsor organisation

  Inari Medical Europe GmbH

• Clinicaltrials.gov Identifier

  NCT06588634

• Duration of Study in the UK

  1 years, 7 months, 31 days

• Research summary

  This study is a post-market, prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to Standard of Care Therapy for high-risk acute Pulmonary Embolism (PE). Standard of Care Therapy for this condition includes: anticoagulation, systemic thrombolysis, surgical embolectomy as primary interventions, and extracorporeal membrane oxygenation (ECMO). The study will collect data on demographics, comorbidities, details from the PE diagnosis and treatment, and clinical and functional outcomes through 3-month follow-up.

  The primary study objective is to compare the in-hospital clinical outcomes of patients with high-risk acute pulmonary embolism (PE) treated with the FlowTriever System plus anticoagulation versus Standard of Care Therapy.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  25/EE/0068

• Date of REC Opinion

  16 Apr 2025

• REC opinion

  Favourable Opinion