Clinical trial NCT06588634: The PERSEVERE Study
Official title: The PERSEVERE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Pulmonary Thromboembolism
Keywords: PE
Pulmonary Embolism
FlowTriever
CDT
Catheter Directed Thrombolysis
Anticoagulation
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 outcomes:
measure: Composite clinical endpoint of the following adjudicated events:
timeFrame: The earlier of initial hospital discharge or 7 days after randomization
Secondary outcomes:
measure: All-cause mortality
timeFrame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
measure: Cardiac arrest
timeFrame: At the earlier of initial hospital discharge or 7 days post randomization
measure: Bailout to an alternative therapeutic strategy
timeFrame: At the earlier of initial hospital discharge or 7 days post randomization
measure: Major bleeding
timeFrame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
measure: ECMO life support
timeFrame: 7 days post-randomization
measure: PE-related mortality
timeFrame: 3 months
measure: All-cause and PE-related readmissions
timeFrame: 30 days and 90 days
measure: Days alive outside hospital
timeFrame: 90 days
measure: PE-related quality of life, by PEmb-QoL
timeFrame: 3 months
measure: General health-related quality of life, by EQ-5D-5L
timeFrame: 3 months
measure: Post-PE Impairment diagnosis
timeFrame: 3 months
measure: Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline
timeFrame: 72 hours
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Buffalo
country: United States
facility: SUNY, The University at Buffalo
state: New York
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: HCA Tristar/Centennial
state: Tennessee
city: San Antonio
country: United States
facility: HCA Methodist Health San Antonio
state: Texas
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Regensburg
country: Germany
facility: Universitätsklinik Regensburg
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron, Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario La Paz Madrid
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France
name: Nicolas Meneveau, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany
name: Stavros Konstantinides, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA
name: John M Moriarty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn Medicine, Philadelphia, PA, USA
name: Jay Giri, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: