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

• ClinicalTrials.gov Identifier: NCT03761173
• Recruitment Status: Enrolling by invitation
• First Posted: December 3, 2018
• Last Update Posted: May 17, 2023
• Sponsor: Inari Medical
• 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: May 17, 2023
• Actual Study Start Date: December 15, 2018
• Estimated Primary Completion Date: September 30, 2023 (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

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 (FLASH)

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 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 treatment for pulmonary embolism.

Condition

• PE - Pulmonary Embolism
• PE - Pulmonary Thromboembolism

Intervention

• Device: FlowTriever System
  Thrombectomy
• Drug: Anticoagulation Agents
  Anticoagulation medication

Study Groups/Cohorts

• FlowTriever
  Mechanical thrombectomy for pulmonary embolism
  Intervention: Device: FlowTriever System
• Conservative Therapy Sub-Study
  Anticoagulation medication for pulmonary embolism (as directed by treating physician)
  Intervention: Drug: Anticoagulation Agents

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: August 2, 2021): 1300
• Original Estimated Enrollment (submitted: November 29, 2018): 500
• Estimated Study Completion Date: June 30, 2024
• Estimated Primary Completion Date: September 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

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: Austria, Belgium, France, Germany, Netherlands, Spain, Switzerland, United Kingdom, United States

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

• Current Responsible Party: Inari Medical
• Original Responsible Party: Same as current
• Current Study Sponsor: Inari Medical
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Catalin Toma, MD; University of Pittsburgh

• PRS Account: Inari Medical
• Verification Date: May 2023