Study Results
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View full resultsBasic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2016-04-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FlowTriever System
FlowTriever System
Interventions
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FlowTriever System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Inari Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Rosenfield, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Victor Tapson, MD
Role: STUDY_CHAIR
Cedars-Sinai Medical Center
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15-001
Identifier Type: -
Identifier Source: org_study_id
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