FlowTriever2 Pulmonary Embolectomy Clinical Study (FLARE-FT2)

Inari Medical

Status: Completed

Conditions: Pulmonary Embolism

Treatments: Device: FlowTriever2 Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT05560763

21-001

Details and patient eligibility

About

The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 < 130 BPM prior to procedure
• Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment.
• FlowTriever2 Catheter enters the vasculature

Exclusion criteria

• Thrombolytic use within 30 days of baseline CTA
• Pulmonary hypertension with peak pulmonary artery pressure > 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 < 28% (NOTE: hematocrit required within 6 hours of index procedure)
• Platelets < 100,000/μL
• Serum creatinine > 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Completed Cases

Experimental group

Treatment:

Device: FlowTriever2 Catheter