FLowTriever for Acute Massive Pulmonary Embolism (FLAME)

PE - Pulmonary Thromboembolism Clinical Trial

— FLAME  

Official title:

FLowTriever for Acute Massive Pulmonary Embolism (FLAME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795167
• Other study ID #: 20-001
• Status: Completed
• Start date: March 16, 2021
• Est. completion date: December 19, 2022

Study information

• Verified date: September 2023
• Source: Inari Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age >=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions

Exclusion Criteria:

• Out of hospital cardiac arrest with Glasgow Coma Scale of =8
• Witnessed cardiac arrest with ongoing CPR >30 minutes
• Contraindication to anticoagulants, i.e. heparin or alternative
• Hematocrit <28%
• Platelets <25,000/µL
• INR >8
• Intracardiac thrombus and/or intracardiac clot in transit
• Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated
• History of pulmonary hypertension with systolic pulmonary arterial pressure >70 mmHg
• Presence of chronic medical conditions with estimated < 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment)
• Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
• Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)

Related Conditions & MeSH terms

• Embolism
• PE - Pulmonary Embolism
• PE - Pulmonary Thromboembolism
• Pulmonary Embolism
• Thromboembolism

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Gates Vascular Institute / SUNY Buffalo	Buffalo	New York
United States	OhioHealth Riverside	Columbus	Ohio
United States	Inova Fairfax	Falls Church	Virginia
United States	Lenox Hill Hospital / Northwell Health	New York	New York
United States	Penn Presbyterian/Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC	Pittsburgh	Pennsylvania
United States	Beaumont Royal Oak	Royal Oak	Michigan
United States	Ascension Providence Hospital	Southfield	Michigan
United States	Lankenau Medical Center / Pulmonology Associates	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Inari Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite incidence of all-cause mortality, clinical deterioration, bailout, and major bleeding	Endpoint events will be assessed from the time of treatment of the high-risk pulmonary embolism through hospital discharge for the high-risk PE, or through 45 days post treatment for high-risk pulmonary embolism, whichever comes first..	From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, which ever comes first.