Clinical trial NCT02692586: FlowTriever Pulmonary Embolectomy Clinical Study
Official title: FlowTriever Pulmonary Embolectomy Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Acute Pulmonary Embolism
Submassive Pulmonary Embolism
Massive Pulmonary Embolism
Keywords: Thromboembolism
Thrombectomy
Right Heart Strain
Submassive PE
Right Ventricle Dysfunction
Massive PE
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2016-02-26
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in RV/LV Ratio
timeFrame: Baseline to 48 hours
measure: Number of Participants With Major Adverse Events
timeFrame: Within 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: East Alabama Heart & Vascular
state: Alabama
city: Birmingham
country: United States
facility: St. Vincent's
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Danville
country: United States
facility: Ephraim McDowell Regional Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Baptist Health
state: Kentucky
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
Study officials:
affiliation: Massachusetts General Hospital
name: Kenneth Rosenfield, MD
role: STUDY_CHAIR
affiliation: Cedars-Sinai Medical Center
name: Victor Tapson, MD
role: STUDY_CHAIR
References: