FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

N/ACompletedNCT04795167

Inari Medical115 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

115

Conditions

PE - Pulmonary Embolism PE - Pulmonary Thromboembolism

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (11)

Emory University

Atlanta, Georgia, United States

Beaumont Royal Oak

Royal Oak, Michigan, United States

Ascension Providence Hospital

Southfield, Michigan, United States

Outcomes

Primary Outcomes

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.