FlowTriever Pulmonary Embolectomy Clinical Study

Pulmonary Embolism Clinical Trial

— FLARE  

Official title:

FlowTriever Pulmonary Embolectomy Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692586
• Other study ID #: 15-001
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2021
• Source: Inari Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Massive Pulmonary Embolism
• Pulmonary Embolism
• Submassive Pulmonary Embolism

Intervention

Device:
• FlowTriever System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Inari Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in RV/LV Ratio	Change in RV/LV ratio from baseline to 48 hours	Baseline to 48 hours
Primary	Number of Participants With Major Adverse Events	Device-related death, major bleeding, and treatment related AEs	Within 48 hours