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FlowTriever All-Comer Registry for Patient Safety and Hemodynamics

Key facts

Who runs it
Inari Medical
Where
Albany, Atlanta, Aurora, Birmingham, Buffalo, Chicago, Cleveland, Columbia, Denison, Detroit, Evanston, Everett, Falls Church, Germantown, Grand Blanc, Indianapolis, Jacksonville, Knoxville, Lakeland, Lee's Summit, Louisville, Madison Heights, Manhasset, Miami, Milwaukee, Minneapolis, Nashville, New Haven, New York, Newark, Norfolk, Opelousas, Pensacola, Philadelphia, Pittsburgh, Queens, Ridgewood, Rochester, Rockford, Roslyn, Royal Oak, Saint Cloud, Sarasota, Spokane, Tallahassee, Tucson, Valhalla, West Columbia, Winston-Salem, and Ypsilanti, United StatesSee the 59 sitesAlso in 8 other countries, 22 sites
Trial code
Status
Completed
People taking part
1,200 people enrolled
Started
15 Dec 2018
Ended
4 Sept 2024
Type of study
Observational, 2 groups
Treatments tested
  • FlowTriever System
  • Anticoagulation Agents
Record updated
1 October 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated*
  • 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
  • Unable to be anticoagulated with heparin or alternative
  • Diagnosis with a minor PE with a less than 0.9 RV/LV ratio
  • 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

Where in United States

Also in 8 other countries, 22 sites

  • Albany Medical CenterAlbany, United States
  • Emory UniversityAtlanta, United States
  • University of ColoradoAurora, United States
  • UAB Division of Cardiovascular DiseaseBirmingham, United States
  • SUNY, The University at BuffaloBuffalo, United States
  • Rush Medical CenterChicago, United States
  • University of ChicagoChicago, United States
  • University Hospitals Cleveland Medical Center*Cleveland, United States
  • Missouri Cardiovascular SpecialistsColumbia, United States
  • University of Missouri - ColumbiaColumbia, United States
  • CardioVoyageDenison, United States
  • Henry Ford Health SystemDetroit, United States
  • Northwestern UniversityEvanston, United States
  • Providence Regional Medical Center EverettEverett, United States
  • Inova FairfaxFalls Church, United States
  • Methodist Healthcare FoundationGermantown, United States
  • Ascension Genesys HospitalGrand Blanc, United States
  • Indiana University School of MedicineIndianapolis, United States
  • Memorial Hospital JacksonvilleJacksonville, United States
  • UTMC KnoxvilleKnoxville, United States
  • Lakeland Vascular InstituteLakeland, United States
  • Saint Luke's Hospital of Kansas CityLee's Summit, United States
  • Baptist Health LousvilleLouisville, United States
  • Norton HealthcareLouisville, United States
  • Ascension Providence HospitalMadison Heights, United States
  • Northwell HealthManhasset, United States
  • Mount Sinai Medical Center of FloridaMiami, United States
  • Palmetto General HospitalMiami, United States
  • University of MiamiMiami, United States
  • Aurora St. Luke's Medical CenterMilwaukee, United States
  • Metropolitan Heart and Vascular InstituteMinneapolis, United States
  • University of MinnesotaMinneapolis, United States
  • St. Thomas WestNashville, United States
  • Yale UniversityNew Haven, United States
  • Mount SinaiNew York, United States
  • NYU Langone Medical CenterNew York, United States
  • Christiana Care Health ServicesNewark, United States
  • SentaraNorfolk, United States
  • Opelousas GeneralOpelousas, United States
  • Ascension Sacred HeartPensacola, United States
  • Thomas Jefferson UniversityPhiladelphia, United States
  • University of PennsylvaniaPhiladelphia, United States
  • University of Pittsburgh Medical CenterPittsburgh, United States
  • Jamaica HospitalQueens, United States
  • Valley HealthRidgewood, United States
  • Ascension Providence Rochester HospitalRochester, United States
  • Javon Bea HospitalRockford, United States
  • St. Francis Hospital & Heart CenterRoslyn, United States
  • Beaumont HealthRoyal Oak, United States
  • CentraCare Heart & Vascular CenterSaint Cloud, United States
  • Sarasota Memorial HospitalSarasota, United States
  • Providence Sacred HeartSpokane, United States
  • Tallahassee Memorial HospitalTallahassee, United States
  • PIMA Heart and VascularTucson, United States
  • University Of Arizona College Of MedicineTucson, United States
  • Westchester Medical CenterValhalla, United States
  • Lexington Medical CenterWest Columbia, United States
  • Wake Forest Baptist Medical CenterWinston-Salem, United States
  • St. Joseph MercyYpsilanti, United States

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • FlowTriever

    Mechanical thrombectomy for pulmonary embolism

    Treatment: FlowTriever System

  • Conservative Therapy Sub-Study

    Anticoagulation medication for pulmonary embolism (as directed by treating physician)

    Treatment: Anticoagulation Agents

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
Record updated
1 October 2025