Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 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 : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: FlowTriever System
    Thrombectomy

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 thrombectomy 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

Exclusion Criteria:

  • Unable to be anticoagulated with heparin or alternative
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Show Show 25 study locations
Sponsors and Collaborators
Inari Medical
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Thromboembolism
Embolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases