FlowTriever Pulmonary Embolectomy Clinical Study

Launched by INARI MEDICAL · Feb 23, 2016

Keywords

ClinConnect Summary

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Gender

ALL

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 \<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
• • 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