N/A
N=106
FlowTriever Pulmonary Embolectomy Clinical Study
Pulmonary Embolism · Acute Pulmonary Embolism · Submassive Pulmonary Embolism · Massive Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT02692586 ↗Enrolled (actual)
106
Serious AEs
13.2%
Results posted
Apr 2021
Primary outcome: Primary: Change in RV/LV Ratio — 0.38 RV/LV ratio — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FlowTriever System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inari Medical
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in RV/LV Ratio |
0.38 | < 0.0001 sig |
| PRIMARY Number of Participants With Major Adverse Events |
4; 100 | < 0.0001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE
- RV/LV ratio ≥ 0.9 without syncope
- Systolic BP ≥ 90 mmHg
- Stable heart rate 70 mmHg by right heart catheterization
- Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg
- FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- Hematocrit 1.8 mg/dL
- INR > 3
- Major trauma ISS > 15
- Presence of intracardiac lead in right ventricle or 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
- Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
- Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention
- Life expectancy of < 90 days
- Female who is pregnant or nursing
- Current participation in another investigational drug or device treatment study
Data sourced from ClinicalTrials.gov (NCT02692586). 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.