FlowTriever Pulmonary Embolectomy Clinical Study

Completed · Not applicable

Conditions studied: Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism, Massive Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT02692586

Run by

Inari Medical

People needed

106

Starts

2016-04-01

Expected to finish

2017-11-01

Last updated by the study team

2021-05-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• East Alabama Heart & Vascular — Auburn, Alabama, United States
• St. Vincent's — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Florida Hospital — Orlando, Florida, United States
• Sacred Heart Hospital — Pensacola, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Ephraim McDowell Regional Medical Center — Danville, Kentucky, United States
• Baptist Health — Louisville, Kentucky, United States
• East Jefferson General Hospital — Metairie, Louisiana, United States
• North Shore University Hospital — Manhasset, New York, United States
• Ohio State University — Columbus, Ohio, United States
• OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States
• UPMC Hamot — Erie, Pennsylvania, United States
• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Charleston Area Medical Center — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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