N/A
Completed N=1,000
FlowTriever All-Comer Registry for Patient Safety and Hemodynamics
PE - Pulmonary Embolism · PE - Pulmonary Thromboembolism
Source: ClinicalTrials.gov NCT03761173 ↗
Enrolled (actual)
1,000
Serious AEs
12.5%
Results posted
Oct 2025
Primary outcomePrimary: Subjects With Major Adverse Events — 24; 964 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Major Adverse Events |
24; 964 | — |
| SECONDARY Device-Related Mortality |
0; 986 | — |
| SECONDARY Major Bleeding |
17; 970 | — |
| SECONDARY Intraprocedural Device-related or Procedure-related Adverse Events |
8; 979 | — |
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
Data sourced from ClinicalTrials.gov (NCT03761173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.