The PERSEVERE Study

Recruiting now · Not applicable

Conditions studied: Pulmonary Embolism, Pulmonary Thromboembolism

In brief

Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

Key facts

Study ID

NCT06588634

Run by

Inari Medical

People needed

200

Starts

2024-12-16

Expected to finish

2028-02-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Yale University — New Haven, Connecticut, United States (enrolling)
• AdventHealth Orlando — Orlando, Florida, United States (enrolling)
• Orlando Health Regional Medical Center — Orlando, Florida, United States (enrolling)
• Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
• Northwell Health — Bay Shore, New York, United States (enrolling)
• SUNY, The University at Buffalo — Buffalo, New York, United States (enrolling)
• Summa Akron — Akron, Ohio, United States (enrolling)
• UPHS Penn Health System — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• HCA Tristar/Centennial — Nashville, Tennessee, United States (enrolling)
• HCA Medical City Heart & Spine — Dallas, Texas, United States (enrolling)
• HCA Methodist Health San Antonio — San Antonio, Texas, United States (enrolling)
• Besançon University Hospital — Besançon, France (enrolling)
• Hopital Arnaud de Villeneuve, Montpellier — Montpellier, France (enrolling)
• CHU Nîmes Caremeau — Nîmes, France (enrolling)
• Hôpital Européen Georges-Pompidou, Paris — Paris, France (enrolling)
• Klinikum Chemnitz — Chemnitz, Germany (enrolling)
• Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden, Germany (enrolling)
• Universitätsmedizin Mainz — Mainz, Germany (enrolling)
• Munich LMU — München, Germany (enrolling)
• Universitätsklinik Regensburg — Regensburg, Germany (enrolling)
• Hospital Universitari Vall d'Hebron, Barcelona — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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