NCT06588634 · Inari Medical
The PERSEVERE Study
What this study is about
randomly assigned Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. the usual treatment
View original scientific description
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- New Haven, Connecticut
- Orlando, Florida
- Sarasota, Florida
- Atlanta, Georgia
- Jackson, Mississippi
- Bay Shore, New York
- Buffalo, New York
- Akron, Ohio
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
- Dallas, Texas
And 1 more location — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations