FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
- Conditions
- PE - Pulmonary EmbolismPE - Pulmonary Thromboembolism
- Interventions
- Device: FlowTriever SystemDrug: Anticoagulation Agents
- Registration Number
- NCT03761173
- Lead Sponsor
- Inari Medical
- Brief Summary
To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.
Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1186
-
Clinical signs and symptoms consistent with acute PE
-
Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery
-
Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion*
- US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.
-
Unable to be anticoagulated with heparin or alternative
-
Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
-
Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated*
-
Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention*
-
Life expectancy < 30 days, as determined by Investigator
-
Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
- US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description FlowTriever FlowTriever System Mechanical thrombectomy for pulmonary embolism Conservative Therapy Sub-Study Anticoagulation Agents Anticoagulation medication for pulmonary embolism (as directed by treating physician)
- Primary Outcome Measures
Name Time Method Composite Major Adverse Events 48-hours Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events
- Secondary Outcome Measures
Name Time Method Individual Major Adverse Events 48-hours Rate of subjects with individual components of composite MAE
Device-related serious adverse events 30-days Rate of device-related SAEs
All-cause mortality 30-days Rate of deaths
Trial Locations
- Locations (81)
Rush Medical Center
🇺🇸Chicago, Illinois, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Pima Heart and Vascular
🇺🇸Tucson, Arizona, United States
Hopital de la Cavale Blanche - CHU Brest
🇫🇷Brest, France
Cardioangiologisches Centrum Bethanien
🇩🇪Frankfurt, Germany
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Opelousas General
🇺🇸Opelousas, Louisiana, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Ascension Sacred Heart
🇺🇸Pensacola, Florida, United States
Ascension Genesys Hospital
🇺🇸Grand Blanc, Michigan, United States
Methodist Healthcare Foundation
🇺🇸Germantown, Tennessee, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Beaumont Health
🇺🇸Royal Oak, Michigan, United States
St. Joseph Mercy
🇺🇸Ypsilanti, Michigan, United States
UTMC Knoxville
🇺🇸Knoxville, Tennessee, United States
Centre Hospitalier Universitaire de Besançon
🇫🇷Besançon, France
Charité Hospital - Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Helios Kliniken Schwerin
🇩🇪Schwerin, Germany
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Inselspital
🇨ðŸ‡Bern, Switzerland
Unispital
🇨ðŸ‡Zürich, Switzerland
Palmetto General Hospital
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Mount Sinai Medical Center of Florida
🇺🇸Miami, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
UZ Antwerpen
🇧🇪Antwerpen, Belgium
Jamaica Hospital
🇺🇸Queens, New York, United States
Inova Fairfax
🇺🇸Falls Church, Virginia, United States
Sentara
🇺🇸Norfolk, Virginia, United States
Valley Health
🇺🇸Ridgewood, New Jersey, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Missouri, Columbia
🇺🇸Columbia, Missouri, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
CentraCare Heart & Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
SUNY, The University at Buffalo
🇺🇸Buffalo, New York, United States
Saint Luke's Hospital of Kansas City
🇺🇸Lee's Summit, Missouri, United States
Lexington Medical Center
🇺🇸West Columbia, South Carolina, United States
Mount Sinai
🇺🇸New York, New York, United States
Northwell Health
🇺🇸Manhasset, New York, United States
CardioVoyage
🇺🇸Denison, Texas, United States
Missouri Cardiovascular Specialists
🇺🇸Columbia, Missouri, United States
CHU Grenoble
🇫🇷Grenoble, France
St. Francis Hospital & Heart Center
🇺🇸Roslyn, New York, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
Hospital ClÃnico San Carlos
🇪🇸Madrid, Spain
Albany Medical Center
🇺🇸Albany, New York, United States
Providence Sacred Heart
🇺🇸Spokane, Washington, United States
Allgemeines Krankenhaus AKH Wien
🇦🇹Vienna, Austria
UZ Brussel
🇧🇪Brussel, Belgium
Institut Coeur Poumon - CHU de Lille
🇫🇷Lille, France
European Hospital Georges Pompidou
🇫🇷Paris, France
The Royal London Hospital, Bart's Health
🇬🇧London, United Kingdom
Gregorio Maranon University Hospital
🇪🇸Madrid, Spain
HCL Hôpital Louis Pradel - Hôpital Cardiologique
🇫🇷Lyon, France
University Hospital
🇩🇪Heidelberg, Germany
The Royal Free Hospital
🇬🇧London, United Kingdom
Universitatsklinikum des Saarlandes
🇩🇪Homburg, Germany
Kantonsspital Sankt Gallen
🇨ðŸ‡Saint Gallen, Switzerland
Metropolitan Heart and Vascular Institute
🇺🇸Minneapolis, Minnesota, United States
St. Thomas West
🇺🇸Nashville, Tennessee, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Memorial Hospital Jacksonville
🇺🇸Jacksonville, Florida, United States
UAB Division of Cardiovascular Disease
🇺🇸Birmingham, Alabama, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Arizona College of Medicine
🇺🇸Tucson, Arizona, United States
Lakeland Vascular Institute
🇺🇸Lakeland, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Northwestern University
🇺🇸Evanston, Illinois, United States
Javon Bea Hospital
🇺🇸Rockford, Illinois, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
Baptist Health Lousville
🇺🇸Louisville, Kentucky, United States
Ascension Providence Hospital
🇺🇸Madison Heights, Michigan, United States
Ascension Providence Rochester Hospital
🇺🇸Rochester, Michigan, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States