FlowTriever All-Comer Registry for Patient Safety and Hemodynamics

Study 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).

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

Conditions
-----------------
PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism

Intervention / Treatment
-----------------
* Device: FlowTriever System
* Drug: Anticoagulation Agents


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FlowTriever<br>Mechanical thrombectomy for pulmonary embolism | Device: FlowTriever System<br>* Thrombectomy<br>|
| Conservative Therapy Sub-Study<br>Anticoagulation medication for pulmonary embolism (as directed by treating physician) | Drug: Anticoagulation Agents<br>* Anticoagulation medication<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Major Adverse Events | Rate of subjects with composite of device-related death, major bleeding, device or procedure-related adverse events | 48-hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Major Adverse Events | Rate of subjects with individual components of composite MAE | 48-hours | 
| All-cause mortality | Rate of deaths | 30-days | 
| Device-related serious adverse events | Rate of device-related SAEs | 30-days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, Anticoagulation Medication