The PERSEVERE Study

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism; Pulmonary Thromboembolism
• Intervention / Treatment: Device: FlowTriever System; Procedure: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tine Devolder; Phone Number: +32 476 53 88 05; Email: tine.devolder@inarimedical.com
• Study Contact Backup: Name: Jen Foss; Phone Number: 978-587-6598; Email: jenifer.foss@stryker.com

Study Locations

• France
  • Besançon, France, 25030
    • Recruiting
    • Besançon University Hospital
    • Contact: Nicolas Meneveau, MD, PhD
  • Montpellier, France
    • Recruiting
    • Hopital Arnaud de Villeneuve, Montpellier
    • Contact: Francoise Roubille, MD
  • Nîmes, France
    • Recruiting
    • CHU Nîmes Caremeau
    • Contact: Benoit Lattuca, MD, PhD
  • Paris, France
    • Recruiting
    • Hôpital Européen Georges-Pompidou, Paris
    • Contact: Olivier Sanchez, MD, PhD
• Germany
  • Chemnitz, Germany
    • Recruiting
    • Klinikum Chemnitz
    • Contact: Karim Ibrahim, MD
  • Dresden, Germany
    • Recruiting
    • Universitätsklinikum Carl Gustav Carus an der TU Dresden
    • Contact: Ralf-Thorsten Hoffmann, MD
  • Mainz, Germany, 55131
    • Recruiting
    • Universitätsmedizin Mainz
    • Contact: Stavros Konstantinides, MD, PhD
  • München, Germany
    • Recruiting
    • Munich LMU
    • Contact: Konstantin Stark, MD
  • Regensburg, Germany
    • Recruiting
    • Universitätsklinik Regensburg
    • Contact: Stefan Stadler, MD
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Universitari Vall d'Hebron, Barcelona
    • Contact: Juan Carlos Ruiz, MD, PhD
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz Madrid
    • Contact: Raul Moreno, MD, PhD
• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel
    • Contact: Gregor Leibundgut, MD
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Royal Free Hospital London
    • Contact: Tushar Kotecha, MBChB, PhD
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale University
      • Contact: Christopher Moore, MD
  • Florida
    • Orlando, Florida, United States, 32806
      • Recruiting
      • Orlando Health Regional Medical Center
      • Contact: Joel Garcia-Fernandez, MD
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Hospital
      • Contact: Clinton Wrigley, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Contact: Wissam Jaber, MD
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • University of Mississippi Medical Center
      • Contact: Gabriel Hernandez, MD
  • New York
    • Bay Shore, New York, United States, 11706
      • Recruiting
      • Northwell Health
      • Contact: Wally Omar, MD
    • Buffalo, New York, United States, 14203
      • Recruiting
      • SUNY, The University at Buffalo
      • Contact: David Zlotnick, MD
  • Ohio
    • Akron, Ohio, United States, 44304
      • Recruiting
      • Summa Akron
      • Contact: Mark Rea, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • UPHS Penn Health System
      • Contact: Taisei Kobayashi, MD
      • Contact: Russell Rosenberg, MD
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny General Hospital
      • Contact: Mithun Chakravarthy, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • HCA Tristar/Centennial
      • Contact: Samuel Horr, MD
  • Texas
    • Dallas, Texas, United States, 75039
      • Recruiting
      • HCA Medical City Heart & Spine
      • Contact: Srinivas Yallapragada, MD
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • HCA Methodist Health San Antonio
      • Contact: Chandra Kunavarapu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Procedure: Standard of Care; Standard of care treatment for pulmonary embolism
Active Comparator: FlowTriever	Device: FlowTriever System; Mechanical thrombectomy for pulmonary embolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite clinical endpoint of the following adjudicated events:	All-cause mortality; Cardiac arrest; Bailout to an alternative therapeutic strategy; Major bleeding; ECMO life support	The earlier of initial hospital discharge or 7 days after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Inari Medical
• Investigators: Principal Investigator: Nicolas Meneveau, MD PhD, Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France; Principal Investigator: Stavros Konstantinides, MD PhD, Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany; Principal Investigator: John M Moriarty, MD, Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA; Principal Investigator: Jay Giri, MD, MPH, Penn Medicine, Philadelphia, PA, USA

Publications and helpful links

General 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.2025.107331. Epub 2025 Dec 24.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Anticoagulation; PE; Pulmonary Embolism; FlowTriever; CDT; Catheter Directed Thrombolysis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 24-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes