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Purpose

Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
FlowTriever
  • Device: FlowTriever System
    Mechanical thrombectomy for pulmonary embolism
Active Comparator
Standard of Care
  • Procedure: Standard of Care
    Standard of care treatment for pulmonary embolism

Recruiting Locations

Yale University
New Haven 4839366, Connecticut 4831725 06519
Contact:
Christopher Moore, MD

Orlando Health Regional Medical Center
Orlando 4167147, Florida 4155751 32806
Contact:
Joel Garcia-Fernandez, MD

Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
Contact:
Clinton Wrigley, MD

Emory University
Atlanta 4180439, Georgia 4197000 30322
Contact:
Wissam Jaber, MD

University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296 39216
Contact:
Gabriel Hernandez, MD

Northwell Health
Bay Shore 5108169, New York 5128638 11706
Contact:
Wally Omar, MD

SUNY, The University at Buffalo
Buffalo 5110629, New York 5128638 14203
Contact:
David Zlotnick, MD

UPHS Penn Health System
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Taisei Kobayashi, MD

Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212
Contact:
Mithun Chakravarthy, MD

HCA Tristar/Centennial
Nashville 4644585, Tennessee 4662168 37203
Contact:
Samuel Horr, MD

HCA Medical City Heart & Spine
Dallas 4684888, Texas 4736286 75039
Contact:
Srinivas Yallapragada, MD

HCA Methodist Health San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Chandra Kunavarapu, MD

More Details

Status
Recruiting
Sponsor
Inari Medical

Study Contact

Tine Devolder
+32 476 53 88 05
tine.devolder@inarimedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.