The PERSEVERE Study

Overview

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

Interventions

• Device FlowTriever System
  Mechanical thrombectomy for pulmonary embolism
• Procedure Standard of Care
  Standard of care treatment for pulmonary embolism

Primary outcome measures

• Composite clinical endpoint of the following adjudicated events: [Time frame: The earlier of initial hospital discharge or 7 days after randomization]

Secondary outcome measures (12)

• All-cause mortality [Time frame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit]
• Cardiac arrest [Time frame: At the earlier of initial hospital discharge or 7 days post randomization]
• Bailout to an alternative therapeutic strategy [Time frame: At the earlier of initial hospital discharge or 7 days post randomization]
• Major bleeding [Time frame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit]
• ECMO life support [Time frame: 7 days post-randomization]
• PE-related mortality [Time frame: 3 months]
• All-cause and PE-related readmissions [Time frame: 30 days and 90 days]
• Days alive outside hospital [Time frame: 90 days]
• PE-related quality of life, by PEmb-QoL [Time frame: 3 months]
• General health-related quality of life, by EQ-5D-5L [Time frame: 3 months]
• Post-PE Impairment diagnosis [Time frame: 3 months]
• Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline [Time frame: 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 15 centers

• Yale University — New Haven
• AdventHealth Orlando — Orlando
• Orlando Health Regional Medical Center — Orlando
• Sarasota Memorial Hospital — Sarasota
• Emory University — Atlanta
• University of Mississippi Medical Center — Jackson
• Northwell Health — Bay Shore
• SUNY, The University at Buffalo — Buffalo
• … and 7 more centers

Germany · 5 centers

• Klinikum Chemnitz — Chemnitz
• Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden
• Universitätsmedizin Mainz — Mainz
• Munich LMU — München
• Universitätsklinik Regensburg — Regensburg

France · 4 centers

• Besançon University Hospital — Besançon
• Hopital Arnaud de Villeneuve, Montpellier — Montpellier
• CHU Nîmes Caremeau — Nîmes
• Hôpital Européen Georges-Pompidou, Paris — Paris

Spain · 2 centers

• Hospital Universitari Vall d'Hebron, Barcelona — Barcelona
• Hospital Universitario La Paz Madrid — Madrid

Switzerland · 1 center

• University Hospital Basel — Basel

United Kingdom · 1 center

• Royal Free Hospital London — London

Publications

• Chopard R, Hobohm L, Barco S, Bangalore S, Giri J, Mahfoud F, Moriarty J, Rosenkranz S, Sharp A, Thiele H, Toma C, Tapson VF, Markovitz CD, Rosenberg SP, Konstantinides S, Meneveau N. Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial. Am Heart J. 2026 Apr;294:107331. doi: 10.1016/j.ahj.20 PMID 41453591

Identifiers

NCT: NCT06588634 · 24-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗