Clinical trial NCT04795167: FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
Official title: FlowTriever for Acute Massive Pulmonary Embolism (FLAME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PE - Pulmonary Embolism
PE - Pulmonary Thromboembolism
Keywords: PE
pulmonary embolism
thromboembolism
thrombectomy
FlowTriever
massive pulmonary embolism
high risk pulmonary embolism
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high-risk (massive) pulmonary embolism.

Brief 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 \<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)

Primary outcomes:
measure: Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Secondary outcomes:
measure: All-Cause Mortality
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Bailout to an Alternative Thrombus Removal Strategy
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Clinical Deterioration
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Major Bleeding
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Frequency of Stroke
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Device-related Complications
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Access Site Injury Requiring Intervention, Both Venous and Arterial
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Other outcomes:
measure: Length of Hospital Stay
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Length of ICU Stay
timeFrame: From treatment start or ICU admission, whichever is later, to ICU discharge
measure: Use of ECMO
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Discharge Location
timeFrame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
measure: Time to Extubation
timeFrame: From the time of initiation of primary treatment to extubation
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Royal Oak
country: United States
facility: Beaumont Royal Oak
state: Michigan
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
city: Buffalo
country: United States
facility: Gates Vascular Institute / SUNY Buffalo
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital / Northwell Health
state: New York
city: Columbus
country: United States
facility: OhioHealth Riverside
state: Ohio
city: Philadelphia
country: United States
facility: Penn Presbyterian/Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center / Pulmonology Associates
state: Pennsylvania
city: Falls Church
country: United States
facility: Inova Fairfax
state: Virginia
Study officials:
affiliation: OhioHealth Riverside
name: Mitchell Silver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Medical Center
name: James Horowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silver MJ, Gibson CM, Giri J, Khandhar S, Jaber W, Toma C, Mina B, Bowers T, Greenspon L, Kado H, Zlotnick DM, Chakravarthy M, DuCoffe AR, Butros P, Horowitz JM. Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study. Circ Cardiovasc Interv. 2023 Oct;16(10):e013406. doi: 10.1161/CIRCINTERVENTIONS.123.013406. Epub 2023 Oct 17.