N/A
N=115
FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
PE - Pulmonary Embolism · PE - Pulmonary Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT04795167 ↗Enrolled (actual)
115
Serious AEs
47.0%
Results posted
Sep 2024
Primary outcome: Primary: Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding — 9; 39 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inari Medical
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding |
9; 39 | — |
| SECONDARY All-Cause Mortality |
1; 18 | — |
| SECONDARY Bailout to an Alternative Thrombus Removal Strategy |
2; 16 | — |
| SECONDARY Clinical Deterioration |
8; 13 | — |
| SECONDARY Major Bleeding |
6; 15 | — |
| SECONDARY Frequency of Stroke |
1; 4 | — |
| SECONDARY Device-related Complications |
12; 10 | — |
| SECONDARY Access Site Injury Requiring Intervention, Both Venous and Arterial |
4; 5 | — |
Summary
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
Eligibility Criteria
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 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)
Data sourced from ClinicalTrials.gov (NCT04795167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.