FLowTriever for Acute Massive Pulmonary Embolism (FLAME)

Completed

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

Recruitment & Eligibility

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 Outcome Measures

Name	Time	Method
Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding	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 Outcome Measures

Name	Time	Method
All-Cause Mortality	From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.	Incidence of mortality
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.	Incidence of bailout to an alternative thrombus removal strategy
Clinical Deterioration	From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.	Incidence of clinical deterioration
Major Bleeding	From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.	Incidence of major bleeding
Frequency of Stroke	From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.	Incidence of ischemic or hemorrhagic stroke
Device-related Complications	From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.	Incidence of device-related complications
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.	Incidence of access site injury requiring intervention, including both venous and arterial

Locations (11): Emory University
🇺🇸
Atlanta, Georgia, United States
Beaumont Royal Oak
🇺🇸
Royal Oak, Michigan, United States
Ascension Providence Hospital
🇺🇸
Southfield, Michigan, United States
OhioHealth Riverside
🇺🇸
Columbus, Ohio, United States
Lenox Hill Hospital / Northwell Health
🇺🇸
New York, New York, United States
Gates Vascular Institute / SUNY Buffalo
🇺🇸
Buffalo, New York, United States
Penn Presbyterian/Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
UPMC
🇺🇸
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center / Pulmonology Associates
🇺🇸
Wynnewood, Pennsylvania, United States
Inova Fairfax
🇺🇸
Falls Church, Virginia, United States