The PERSEVERE Study

Launched by INARI MEDICAL · Sep 6, 2024

Keywords

ClinConnect Summary

The PERSEVERE Study is a clinical trial that aims to compare two treatments for patients suffering from high-risk pulmonary embolism (PE), a serious condition where blood clots block blood vessels in the lungs. Specifically, the trial is looking at a new device called the FlowTriever System and comparing it to the standard treatment currently used. This study is open to adults aged 18 and older who have clear evidence of a significant blockage in their lungs and show signs of strain on the right side of the heart.

Participants in the trial can expect to be randomly assigned to receive either the FlowTriever treatment or the standard care. To be eligible, individuals must be able to start treatment quickly, within four hours of enrollment, and must be able to consent to participate. However, certain conditions, such as recent strokes or severe bleeding issues, may prevent someone from joining the study. This research is essential as it could help improve treatment options for people with this serious condition and potentially save lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age at enrollment ≥18 years
• • 2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
• • 3. High-risk class of acute PE
• • 4. RV dysfunction, as defined RV/LV ratio ≥1.0
• • 5. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards
• Exclusion Criteria:
• • 1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
• • 2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
• • 3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
• • 4. Recent stroke (\<14 days)
• • 5. Recent cranial or spinal surgery (\<14 days)
• • 6. Life-threatening active bleeding or hemorrhage into a critical area
• • 7. Known intracranial tumor
• • 8. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator
• • 9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
• • 10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
• • 11. Current participation in another drug or device study that may interfere with the conduct of this trial
• • 12. Ventricular arrhythmias refractory to treatment at the time of enrollment
• • 13. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling
• • 14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
• • 15. Subject was previously enrolled in this study
• • 16. Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization