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FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03761173
Recruitment Status : Enrolling by invitation
First Posted : December 3, 2018
Last Update Posted : April 19, 2022
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Study Description
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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).


Condition or disease Intervention/treatment
PE - Pulmonary Embolism PE - Pulmonary Thromboembolism Device: FlowTriever System Drug: Anticoagulation Agents

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
Actual Study Start Date : December 15, 2018
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
FlowTriever
Mechanical thrombectomy for pulmonary embolism
 Device: FlowTriever System
Thrombectomy
Conservative Therapy Sub-Study
Anticoagulation medication for pulmonary embolism (as directed by treating physician)
 Drug: Anticoagulation Agents
Anticoagulation medication


Outcome Measures
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Primary Outcome Measures :
  1. Composite Major Adverse Events [ Time Frame: 48-hours ]
    Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events


Secondary Outcome Measures :
  1. Individual Major Adverse Events [ Time Frame: 48-hours ]
    Rate of subjects with individual components of composite MAE

  2. All-cause mortality [ Time Frame: 30-days ]
    Rate of deaths

  3. Device-related serious adverse events [ Time Frame: 30-days ]
    Rate of device-related SAEs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring treatment for pulmonary embolism.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03761173


Locations
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Sponsors and Collaborators
Inari Medical
More Information
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Additional Information:

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Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT03761173    
Other Study ID Numbers: 18-002
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inari Medical:
PE
pulmonary embolism
thromboembolism
 thrombectomy
FlowTriever
Anticoagulation Medication
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Anticoagulants