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FlowTriever® system for acute massive pulmonary embolism (PE)

FLAME Study

NCT04795167

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FLAME | Stryker

Design

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Objective

  • Evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism who have received treatment with the FlowTriever system compared to a pre-specified meta-analytic performance goal


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Design

  • Prospective, multicenter, nonrandomized, parallel group, observational study | Three Registries: FlowTriever, Context, and Prior Therapy
  • 115 subjects enrolled at 11 US sites following a successful interim analysis allowing early closure of the study
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Primary Endpoint

  • In-hospital composite of all-cause mortality, bailout, clinical deterioration, and major bleeding




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Key Eligibility Criteria

High-risk pulmonary embolism with one or more of the following:

  • Systolic blood pressure <90 mmHg for at least 15 minutes or drop of >40 mmHg in systolic blood pressure for at least 15 minutes
  • Need for vasopressor support
  • Resuscitation after cardiac arrest with <30 minutes of CPR and Glasgow Coma Scale >8
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Duration of Patient Follow-up

  • Patients were followed through hospital discharge or were exited at 45 days if still in hospital





     

Outcomes

The largest prospective study of
interventional treatment in high-risk PE

A total of 115 high-risk PE patients were enrolled and treated with either FlowTriever or other contemporary therapies, per physician discretion.

High-risk PE Patients
(n=115)

Context Arm*
(n=61)

Patients treated with:

  • Systemic thrombolysis (68.9%)
  • Anticoagulation alone (23.0%)
  • Catheter directed thrombolytics (6.6%)
  • Surgical thrombectomy (1.6%)

FlowTriever Arm
(n=53)

Front-line FlowTriever

Prior Treatment Arm
(n=1)

Non-high-risk PE patients 

who received advanced therapy but progressed to high-risk PE in the same setting

Significantly Lower In-Hospital
Adverse Outcomes

Primary Endpoint†

Low Mortality
in High-Risk PE

All-Cause In-Hospital Mortality

Read the Peer-Reviewed FLAME Results

Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies

See Results