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Comparing FlowTriever System to Standard Care for High-Risk Pulmonary Embolism

The PERSEVERE Study

Not applicable Interventional Inari Medical · NCT06588634

This study tests if the FlowTriever System can help people with high-risk pulmonary embolism feel better compared to standard treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorInari Medical Industry-sponsored
Locations26 sites (New Haven, Connecticut and 25 other locations)
Trial IDNCT06588634 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the FlowTriever System compared to standard care in treating patients with high-risk pulmonary embolism (PE). It involves a randomized controlled trial design, focusing on patients who have objective evidence of a proximal filling defect in their pulmonary arteries and exhibit right ventricular dysfunction. The study aims to determine if the FlowTriever System can improve outcomes for these patients compared to traditional treatment methods.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with high-risk acute pulmonary embolism and evidence of right ventricular dysfunction.

Not a fit: Patients with prolonged cardiac arrest, recent strokes, or those with known chronic thromboembolic pulmonary hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from high-risk pulmonary embolism.

How similar studies have performed: Other studies have shown promise with catheter-directed interventions for pulmonary embolism, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

New Haven, Connecticut and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary EmbolismPulmonary ThromboembolismPEFlowTrieverCDTCatheter Directed ThrombolysisAnticoagulation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.