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

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ClinicalTrials.gov Identifier: NCT03761173
Recruitment Status : Enrolling by invitation
First Posted : December 3, 2018
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Tracking Information
First Submitted Date November 28, 2018
First Posted Date December 3, 2018
Last Update Posted Date August 14, 2019
Actual Study Start Date December 15, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 29, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03761173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 30, 2018)
  • Individual Major Adverse Events [ Time Frame: 48-hours ]
    Rate of subjects with individual components of composite MAE
  • All-cause mortality [ Time Frame: 30-days ]
    Rate of deaths
  • Device-related serious adverse events [ Time Frame: 30-days ]
    Rate of device-related SAEs
Original Secondary Outcome Measures
 (submitted: November 29, 2018)
  • Individual Major Adverse Events [ Time Frame: 48-hours ]
    Rate of subjects with individual components of composite MAE
  • All-cause mortality [ Time Frame: 30-days ]
    Rate of deaths
  • Device-related serious adverse events [ Time Frame: 30-days ]
    Rate of device-related SAEs
  • Change in pulmonary artery pressure [ Time Frame: During procedure ]
    Rate of subjects with change in PAP
  • Change in cardiac index [ Time Frame: During procedure ]
    Rate of subjects with change in cardiac index
  • Change in stroke volume index [ Time Frame: During procedure ]
    Rate of subjects with change in stroke volume index
  • Change in right ventricle stroke work index [ Time Frame: During procedure ]
    Rate of subjects with change in right ventricle stroke work index
  • Change in pulmonary artery pulsatility index [ Time Frame: During procedure ]
    Rate of subjects with change in pulmonary artery pulsatility index
  • Change in total pulmonary vascular resistance [ Time Frame: During procedure ]
    Rate of subjects with change in total pulmonary vascular resistance
  • RV/LV Change [ Time Frame: 48-hours, 30-days, 6-months ]
    Change in RV/LV ratio from baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
Official Title FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients requiring thrombectomy treatment for pulmonary embolism.
Condition
  • PE - Pulmonary Embolism
  • PE - Pulmonary Thromboembolism
Intervention Device: FlowTriever System
Thrombectomy
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: November 29, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical signs and symptoms consistent with acute PE
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03761173
Other Study ID Numbers 18-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Inari Medical
Study Sponsor Inari Medical
Collaborators Not Provided
Investigators Not Provided
PRS Account Inari Medical
Verification Date August 2019