Status:
RECRUITING
The PERSEVERE Study
Lead Sponsor:
Inari Medical
Conditions:
Pulmonary Embolism
Pulmonary Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
Eligibility Criteria
Inclusion
- Age at enrollment ≥18 years
- Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
- High-risk class of acute PE
- RV dysfunction, as defined RV/LV ratio ≥1.0
- 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
- Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
- Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
- Recent stroke (\<14 days)
- Recent cranial or spinal surgery (\<14 days)
- Life-threatening active bleeding or hemorrhage into a critical area
- Known intracranial tumor
- End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator
- Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
- Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
- Current participation in another drug or device study that may interfere with the conduct of this trial
- Ventricular arrhythmias refractory to treatment at the time of enrollment
- 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
- Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
- Subject was previously enrolled in this study
- 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
Key Trial Info
Start Date :
December 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06588634
Start Date
December 16 2024
End Date
August 31 2027
Last Update
January 7 2026
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06519
2
Orlando Health Regional Medical Center
Orlando, Florida, United States, 32806
3
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
4
Emory University
Atlanta, Georgia, United States, 30322