The PERSEVERE Study

Not Applicable

Recruiting

• Conditions: Pulmonary Embolism; Pulmonary Thromboembolism
• Interventions: Device: FlowTriever System; Procedure: Standard of Care

• Registration Number: NCT06588634
• Lead Sponsor: Inari Medical

Brief Summary

RCT of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2024-12-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-12-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FlowTriever	FlowTriever System	-
Standard of Care	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
Composite clinical endpoint of the following adjudicated events:	The earlier of initial hospital discharge or 7 days after randomization	1. All-cause mortality; 2. Cardiac arrest; 3. Bailout to an alternative therapeutic strategy; 4. Major bleeding; 5. ECMO life support

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

Universitätsklinik Regensburg; 🇩🇪 Regensburg, Germany

Hospital Universitari Vall d'Hebron, Barcelona; 🇪🇸 Barcelona, Spain

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

SUNY, The University at Buffalo; 🇺🇸 Buffalo, New York, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

HCA Tristar/Centennial; 🇺🇸 Nashville, Tennessee, United States

HCA Methodist Health San Antonio; 🇺🇸 San Antonio, Texas, United States

Universitätsmedizin Mainz; 🇩🇪 Mainz, Germany

Hospital Universitario La Paz Madrid; 🇪🇸 Madrid, Spain

University Hospital Basel; 🇨🇭 Basel, Switzerland