FLowTriever for Acute Massive Pulmonary Embolism (FLAME)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inari Medical
- Enrollment
- 115
- Locations
- 11
- Primary Endpoint
- Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding
Study Overview
Brief Summary
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Outcomes
Primary Outcomes
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
- 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.)
- Device-related Complications(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)
- Access Site Injury Requiring Intervention, Both Venous and Arterial(From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.)