FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH)
Overview
- Phase
- Not Applicable
- Intervention
- FlowTriever System
- Conditions
- PE - Pulmonary Embolism
- Sponsor
- Inari Medical
- Enrollment
- 1200
- Locations
- 81
- Primary Endpoint
- Subjects With Major Adverse Events
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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).
Investigators
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
Arms & Interventions
FlowTriever
Mechanical thrombectomy for pulmonary embolism
Intervention: FlowTriever System
Conservative Therapy Sub-Study
Anticoagulation medication for pulmonary embolism (as directed by treating physician)
Intervention: Anticoagulation Agents
Outcomes
Primary Outcomes
Subjects With Major Adverse Events
Time Frame: 48-hours after index procedure
MAEs are defined as a composite, when one or more of the following events occur: * Device-related mortality through 48 hours after the index procedure, or * Major bleeding through 48 hours after the index procedure, or * Intra-procedural device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor.
Secondary Outcomes
- Device-Related Mortality(48-hours after the index procedure)
- Major Bleeding(48 hours after index procedure)
- Intraprocedural Device-related or Procedure-related Adverse Events(Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.)