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)
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
Trial sites (29)
Facility
City
Region
Status
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.
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