Pulmonary Embolism, Pulmonary Thromboembolism
Conditions
Keywords
PE, Pulmonary Embolism, FlowTriever, CDT, Catheter Directed Thrombolysis, Anticoagulation
Brief summary
Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
Interventions
DEVICEFlowTriever System
Mechanical thrombectomy for pulmonary embolism
PROCEDUREStandard of Care
Standard of care treatment for pulmonary embolism
Sponsors
Inari Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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 |
Countries
France, Germany, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTTine Devolder
CONTACTJen Foss
PRINCIPAL_INVESTIGATORNicolas Meneveau, MD PhD
Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France
PRINCIPAL_INVESTIGATORStavros Konstantinides, MD PhD
Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany
PRINCIPAL_INVESTIGATORJohn M Moriarty, MD
Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA
PRINCIPAL_INVESTIGATORJay Giri, MD, MPH
Penn Medicine, Philadelphia, PA, USA
Outcome results
None listed