Skip to main content
OpenTrials
Completed

NCT Number: NCT04795167

FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PE - Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases PE - Pulmonary Thromboembolism Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

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

    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.

Secondary outcomes

  1. All-Cause Mortality

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

    Incidence of mortality

  2. Bailout to an Alternative Thrombus Removal Strategy

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

    Incidence of bailout to an alternative thrombus removal strategy

  3. Clinical Deterioration

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

    Incidence of clinical deterioration

  4. Major Bleeding

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

    Incidence of major bleeding

  5. Frequency of Stroke

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

    Incidence of ischemic or hemorrhagic stroke

  6. Device-related Complications

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

    Incidence of device-related complications

  7. Access Site Injury Requiring Intervention, Both Venous and Arterial

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

    Incidence of access site injury requiring intervention, including both venous and arterial

Other outcomes

  1. Length of Hospital Stay

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

    Length of post-treatment hospital stay, measured in number of overnights

  2. Length of ICU Stay

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

    Length of post-treatment ICU stay, measure in number of overnights

  3. Use of ECMO

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

    Frequency of ECMO use, including either pre or post treatment initiation

  4. Discharge Location

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

    Discharge location after hospital stay

  5. Time to Extubation

    Time frame: From the time of initiation of primary treatment to extubation

    Time to extubation reported as number of days

Sponsors and collaborators

Lead sponsor

Inari Medical

Industry

Registry information

Acronym: FLAME

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 12, 2021
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.