Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-12-16
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FlowTriever
FlowTriever System
Mechanical thrombectomy for pulmonary embolism
Standard of Care
Standard of Care
Standard of care treatment for pulmonary embolism
Interventions
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FlowTriever System
Mechanical thrombectomy for pulmonary embolism
Standard of Care
Standard of care treatment for pulmonary embolism
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolas Meneveau, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Hôpital Jean Minjoz, Besançon, France
Stavros Konstantinides, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg-University Mainz, Germany
John M Moriarty, MD
Role: PRINCIPAL_INVESTIGATOR
Westwood Imaging Center & Interventional Radiology Clinic - UCLA, CA, USA
Jay Giri, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Penn Medicine, Philadelphia, PA, USA
Locations
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Yale University
New Haven, Connecticut, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Northwell Health
Bay Shore, New York, United States
SUNY, The University at Buffalo
Buffalo, New York, United States
UPHS Penn Health System
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
HCA Tristar/Centennial
Nashville, Tennessee, United States
HCA Medical City Heart & Spine
Dallas, Texas, United States
HCA Methodist Health San Antonio
San Antonio, Texas, United States
Besançon University Hospital
Besançon, , France
Hopital Arnaud de Villeneuve, Montpellier
Montpellier, , France
CHU Nîmes Caremeau
Nîmes, , France
Hôpital Européen Georges-Pompidou, Paris
Paris, , France
Klinikum Chemnitz
Chemnitz, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, , Germany
Universitätsmedizin Mainz
Mainz, , Germany
Munich LMU
München, , Germany
Universitätsklinik Regensburg
Regensburg, , Germany
Hospital Universitari Vall d'Hebron, Barcelona
Barcelona, , Spain
Hospital Universitario La Paz Madrid
Madrid, , Spain
University Hospital Basel
Basel, , Switzerland
Royal Free Hospital London
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Christopher Moore, MD
Role: primary
Juan Camacho, MD
Role: primary
Wissam Jaber, MD
Role: primary
Gabriel Hernandez, MD
Role: primary
Wally Omar, MD
Role: primary
David Zlotnick, MD
Role: primary
Taisei Kobayashi, MD
Role: primary
Russell Rosenberg, MD
Role: backup
Mithun Chakravarthy, MD
Role: primary
Samuel Horr, MD
Role: primary
Srinivas Yallapragada, MD
Role: primary
Chandra Kunavarapu, MD
Role: primary
Nicolas Meneveau, MD, PhD
Role: primary
Francoise Roubille, MD
Role: primary
Benoit Lattuca, MD, PhD
Role: primary
Olivier Sanchez, MD, PhD
Role: primary
Karim Ibrahim, MD
Role: primary
Ralf-Thorsten Hoffmann, MD
Role: primary
Stavros Konstantinides, MD, PhD
Role: primary
Konstantin Stark, MD
Role: primary
Stefan Stadler, MD
Role: primary
Juan Carlos Ruiz, MD, PhD
Role: primary
Raul Moreno, MD, PhD
Role: primary
Gregor Leibundgut, MD
Role: primary
Tushar Kotecha, MBChB, PhD
Role: primary
Other Identifiers
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24-002
Identifier Type: -
Identifier Source: org_study_id