The PERSEVERE Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInari Medical
About this trial
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- FlowTriever System
- Standard of Care
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
26France
Besançon University Hospital25030, Besançon France
Hopital Arnaud de Villeneuve, Montpellier Montpellier France
CHU Nîmes Caremeau Nîmes France
Hôpital Européen Georges-Pompidou, Paris Paris France
Sponsors and collaborators
Inari Medical
Lead sponsor
Source ClinicalTrials.gov