FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

Inari Medical

Status: Completed

Conditions: PE - Pulmonary Thromboembolism; PE - Pulmonary Embolism

Study type: Observational

Funder types: Industry

Identifiers

NCT04795167

20-001

Details and patient eligibility

About

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

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

115 participants in 3 patient groups

FlowTriever Arm

Description:

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

Context Arm

Description:

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

Prior Therapy Arm

Description:

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