FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

NCT04795167 | Completed Results

• 1 other identifier: 20-001
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

PE - Pulmonary Embolism; PE - Pulmonary Thromboembolism

Keywords

PE; pulmonary embolism; thromboembolism; thrombectomy; FlowTriever; massive pulmonary embolism; high risk pulmonary embolism

Outcome Measures

Primary Outcomes (1)

• Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding

  The primary endpoint is the in-hospital composite endpoint of all-cause mortality, bailout to an alternative thrombus removal strategy, clinical deterioration, and major bleeding (BARC 3b/3c/5a/5b definition). The primary endpoint was assessed in the FlowTriever Arm compared to a pre-specified performance goal of 32%. Subjects in the Context Arm were analyzed separately using descriptive methods. The primary endpoint in the Context Arm was not compared to a performance goal. Data collection for Prior Therapy Arm subjects included information surrounding the PE treatment, progression to High-Risk PE, and patient course through hospital discharge. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.

  From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Secondary Outcomes (7)

• All-Cause Mortality

  From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

• Bailout to an Alternative Thrombus Removal Strategy

  From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

• Clinical Deterioration

  From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

• Major Bleeding

  From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

• Frequency of Stroke

  From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Other Outcomes (5)

• Length of Hospital Stay

  From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

• Length of ICU Stay

  From treatment start or ICU admission, whichever is later, to ICU discharge

• Use of ECMO

  From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.

Study Arms (3)

FlowTriever Arm

FlowTriever Arm subjects are defined as those subjects where FlowTriever is used as the Primary Treatment for pulmonary embolism.

Context Arm

Subjects with high-risk pulmonary embolism who are treated with non-FlowTriever therapies.

Prior Therapy Arm

Subjects presenting with low/intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with high-risk (massive) pulmonary embolism.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inari Medical: lead

Study Sites (11)

Emory University

Atlanta, Georgia, 30308, United States

Location

Beaumont Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Ascension Providence Hospital

Southfield, Michigan, 48075, United States

Location

Gates Vascular Institute / SUNY Buffalo

Buffalo, New York, 14203, United States

Location

Lenox Hill Hospital / Northwell Health

New York, New York, 10075, United States

Location

OhioHealth Riverside

Columbus, Ohio, 43214, United States

Location

Penn Presbyterian/Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Lankenau Medical Center / Pulmonology Associates

Wynnewood, Pennsylvania, 19076, United States

Location

Inova Fairfax

Falls Church, Virginia, 22042, United States

Location

Related Publications (1)

• Silver MJ, Gibson CM, Giri J, Khandhar S, Jaber W, Toma C, Mina B, Bowers T, Greenspon L, Kado H, Zlotnick DM, Chakravarthy M, DuCoffe AR, Butros P, Horowitz JM. Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study. Circ Cardiovasc Interv. 2023 Oct;16(10):e013406. doi: 10.1161/CIRCINTERVENTIONS.123.013406. Epub 2023 Oct 17.

  PMID: 37847768 RESULT

Related Links

• Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study

MeSH Terms

Conditions

Pulmonary Embolism; Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Ashleigh Willson
• Organization: Inari Medical

ashleigh.willson@inarimedical.com

925-330-3446

Study Officials

• Mitchell Silver, MD

  OhioHealth Riverside

  PRINCIPAL INVESTIGATOR

• James Horowitz, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 12, 2021
• Study Start: March 16, 2021
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: April 30, 2025
• Results First Posted: September 20, 2024

Record last verified: 2025-04

Locations

US (11)