NCT02692586CompletedNot Applicable
FlowTriever Pulmonary Embolectomy Clinical Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inari Medical
- Enrollment
- 106
- Locations
- 18
- Primary Endpoint
- Change in RV/LV Ratio
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 <130 BPM prior to procedure
- •Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment
Exclusion Criteria
- •Thrombolytic use within 30 days of baseline CTA
- •Pulmonary hypertension with peak PAP > 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 < 28% within 6 hours of index procedure
- •Platelets < 100,000/µL
- •Serum creatinine > 1.8 mg/dL
- •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
Arms & Interventions
FlowTriever System
Experimental
Intervention: FlowTriever System (Device)
Outcomes
Primary Outcomes
Change in RV/LV Ratio
Time Frame: Baseline to 48 hours
Change in RV/LV ratio from baseline to 48 hours
Number of Participants With Major Adverse Events
Time Frame: Within 48 hours
Device-related death, major bleeding, and treatment related AEs
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (18)
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