FlowTriever Pulmonary Embolectomy Clinical Study

Not Applicable

Completed

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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
FlowTriever System	FlowTriever System	-

Primary Outcome Measures

Name	Time	Method
Change in RV/LV Ratio	Baseline to 48 hours	Change in RV/LV ratio from baseline to 48 hours
Number of Participants With Major Adverse Events	Within 48 hours	Device-related death, major bleeding, and treatment related AEs

Secondary Outcome Measures

Name	Time	Method

Locations (18): East Jefferson General Hospital
🇺🇸
Metairie, Louisiana, United States
St. Vincent's
🇺🇸
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Penn Presbyterian Medical Center
🇺🇸
Philadelphia, Pennsylvania, United States
Emory University
🇺🇸
Atlanta, Georgia, 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
🇺🇸
Pittsburgh, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸
Houston, Texas, United States
Charleston Area Medical Center
🇺🇸
Charleston, West Virginia, United States
East Alabama Heart & Vascular
🇺🇸
Auburn, Alabama, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Sacred Heart Hospital
🇺🇸
Pensacola, Florida, United States
Tampa General Hospital
🇺🇸
Tampa, Florida, United States
Ephraim McDowell Regional Medical Center
🇺🇸
Danville, Kentucky, United States
Baptist Health
🇺🇸
Louisville, Kentucky, United States
UPMC Hamot
🇺🇸
Erie, Pennsylvania, United States