FlowTriever Pulmonary Embolectomy Clinical Study (FLARE)

Inari Medical

Status: Completed

Conditions: Pulmonary Embolism; Acute Pulmonary Embolism; Submassive Pulmonary Embolism; Massive Pulmonary Embolism

Treatments: Device: FlowTriever System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02692586

15-001

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

106 participants in 1 patient group

FlowTriever System

Experimental group

Treatment:

Device: FlowTriever System