N/A
Completed N=50
FlowTriever2 Pulmonary Embolectomy Clinical Study
Source: ClinicalTrials.gov NCT05560763 ↗Enrolled (actual)
50
Serious AEs
20.0%
Results posted
Sep 2025
Primary outcomePrimary: Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) — 0; 50 Participants
Summary
The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) |
0; 50 | — |
| PRIMARY Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg) |
-5.50 | — |
| SECONDARY Secondary Safety Endpoint: Number of Patient Mortalities |
0; 46; 4 | — |
| SECONDARY Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events |
0; 46; 4 | — |
| SECONDARY Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE |
0; 46; 4 | — |
| SECONDARY Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg) |
-8.00 | — |
| SECONDARY Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use |
0; 50 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical signs and symptoms consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio)
- Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
- Stable heart rate 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
- FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- Hematocrit 1.8 mg/dL
- INR > 3
- Major trauma Injury Severity Score (ISS) > 15
- Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
- Cardiovascular or pulmonary surgery within last 7 days
- Actively progressing cancer
- Known bleeding diathesis or coagulation disorder
- Left bundle branch block
- History of severe or chronic pulmonary arterial hypertension
- History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- History of uncompensated heart failure
- History of underlying lung disease that is oxygen dependent
- History of chest irradiation
- History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses heparin or anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot, or non-clot embolus)
- Life expectancy of < 90 days, as determined by Investigator
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
Data sourced from ClinicalTrials.gov (NCT05560763). 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.