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Clinical Trials in the UK / NCT06588634
Recruiting

The PERSEVERE Study

NCT06588634 · tracked via the Priya Life Science UK tracker
Sponsor
Inari Medical
Phase
N/A
Started
2024-12-16
Last updated
2026-09-11

Condition(s) studied

Pulmonary EmbolismPulmonary Thromboembolism

Investigational drug(s) / intervention(s)

FlowTriever SystemStandard of Care

FlowTriever System: Mechanical thrombectomy for pulmonary embolism

Standard of Care: Standard of care treatment for pulmonary embolism

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age at enrollment ≥18 years 2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery 3. High-risk class of acute PE 4. RV dysfunction, as defined RV/LV ratio ≥1.0 5. 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: 1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit. 2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention 3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH 4. Recent stroke (\<14 days) 5. Recent cranial or spinal surgery (\<14 days) 6. Life-threatening active bleeding or hemorrhage into a critical area 7. Known intracranial tumor 8. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator 9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated 10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT) 11. Current participation in another drug or device study that may interfere with the conduct of this trial 12. Ventricular arrhythmias refractory to treatment at the time of enrollment 13. 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 14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions 15. Subject was previously enrolled in this study 16. 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

Primary outcome measure(s)

Trial sites (29)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06588634 on ClinicalTrials.gov ↗ ← All trials in the UK