PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
Conditions
Keywords
PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, massive pulmonary embolism, high risk pulmonary embolism
Brief summary
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
Interventions
None listed
Sponsors
Inari Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Use of ECMO | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. | Frequency of ECMO use, including either pre or post treatment initiation |
| Discharge Location | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. | Discharge location after hospital stay |
| Time to Extubation | From the time of initiation of primary treatment to extubation | Time to extubation reported as number of days |
| Length of ICU Stay | From treatment start or ICU admission, whichever is later, to ICU discharge | Length of post-treatment ICU stay, measure in number of overnights |
| Length of Hospital Stay | From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first. | Length of post-treatment hospital stay, measured in number of overnights |
Countries
United States
Participant flow
Recruitment details
All patients presenting to the hospital/emergency department with PE or who incidentally develop PE while in the hospital were assessed for high-risk PE, and for eligibility for enrollment in the FLAME study.
Pre-assignment details
Subjects who met eligibility criteria for the study and had a primary thrombus removal strategy initiated were enrolled into either the FlowTriever, Context or Prior Therapy Arm, based on the thrombus removal strategy initiated. These three arms were non-randomized parallel registries.
Participants by arm
| Arm | Count |
|---|---|
| FlowTriever Arm Subjects treated with FlowTriever thrombectomy as the primary treatment strategy for high-risk PE. | 53 |
| Context Arm Subjects treated with any other approach as the primary treatment strategy for high-risk PE (including non-FlowTriever mechanical thrombectomy \[0%\], anticoagulation alone \[23.0%\], systemic thrombolysis \[68.9%\], catheter-directed thrombolysis \[6.6%\], or surgical thrombectomy \[1.6%\]) | 61 |
| Prior Therapy Arm Subjects presenting with low- or intermediate-risk PE who received advanced therapy but subsequently progressed to high-risk PE in the same hospital setting/admission | 1 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 18 | 1 |
| Overall Study | Remained in-hospital for >/= 45 Days | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | FlowTriever Arm | Total | Prior Therapy Arm | Context Arm |
|---|---|---|---|---|
| Age, Continuous | 64.8 years | 63.0 years | 58.0 years | 61.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 82 Participants | 0 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 30 Participants | 1 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 56 Participants | 0 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 8 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 33 Participants | 51 Participants | 0 Participants | 18 Participants |
| Region of Enrollment United States | 53 participants | 115 participants | 1 participants | 61 participants |
| Sex: Female, Male Female | 26 Participants | 62 Participants | 1 Participants | 35 Participants |
| Sex: Female, Male Male | 27 Participants | 53 Participants | 0 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 53 | 18 / 61 | 1 / 1 |
| other Total, other adverse events | 10 / 53 | 19 / 61 | 0 / 1 |
| serious Total, serious adverse events | 16 / 53 | 37 / 61 | 1 / 1 |
Outcome results
Primary
Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding
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.
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever Arm and Context Arm. 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding | 9 Participants |
| Context Arm | Composite Incidence of All-cause Mortality, Clinical Deterioration, Bailout, and Major Bleeding | 39 Participants |
Secondary
Access Site Injury Requiring Intervention, Both Venous and Arterial
Incidence of access site injury requiring intervention, including both venous and arterial
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | Access Site Injury Requiring Intervention, Both Venous and Arterial | 4 Participants |
| Context Arm | Access Site Injury Requiring Intervention, Both Venous and Arterial | 5 Participants |
Secondary
All-Cause Mortality
Incidence of mortality
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | All-Cause Mortality | 1 Participants |
| Context Arm | All-Cause Mortality | 18 Participants |
Secondary
Bailout to an Alternative Thrombus Removal Strategy
Incidence of bailout to an alternative thrombus removal strategy
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | Bailout to an Alternative Thrombus Removal Strategy | 2 Participants |
| Context Arm | Bailout to an Alternative Thrombus Removal Strategy | 16 Participants |
Secondary
Clinical Deterioration
Incidence of clinical deterioration
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | Clinical Deterioration | 8 Participants |
| Context Arm | Clinical Deterioration | 13 Participants |
Secondary
Device-related Complications
Incidence of device-related complications
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | Device-related Complications | 12 Participants |
| Context Arm | Device-related Complications | 10 Participants |
Secondary
Frequency of Stroke
Incidence of ischemic or hemorrhagic stroke
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | Frequency of Stroke | 1 Participants |
| Context Arm | Frequency of Stroke | 4 Participants |
Secondary
Major Bleeding
Incidence of major bleeding
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever Arm and Context Arm. Safety data were collected, but not CEC adjudicated or analyzed as outlined for the FlowTriever and Context Arm subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | Major Bleeding | 6 Participants |
| Context Arm | Major Bleeding | 15 Participants |
Other Pre-specified
Discharge Location
Discharge location after hospital stay
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in the FlowTriever, Context and Prior Therapy Arms
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FlowTriever Arm | Discharge Location | Home | 26 Participants |
| FlowTriever Arm | Discharge Location | Home with healthcare | 6 Participants |
| FlowTriever Arm | Discharge Location | Care facility/skilled nursing home | 13 Participants |
| FlowTriever Arm | Discharge Location | Stayed in hospital for >/= 45 days | 4 Participants |
| FlowTriever Arm | Discharge Location | Expired prior to discharge | 1 Participants |
| FlowTriever Arm | Discharge Location | Other | 3 Participants |
| Context Arm | Discharge Location | Other | 6 Participants |
| Context Arm | Discharge Location | Home | 23 Participants |
| Context Arm | Discharge Location | Stayed in hospital for >/= 45 days | 0 Participants |
| Context Arm | Discharge Location | Expired prior to discharge | 18 Participants |
| Context Arm | Discharge Location | Home with healthcare | 3 Participants |
| Context Arm | Discharge Location | Care facility/skilled nursing home | 11 Participants |
| Prior Therapy Arm | Discharge Location | Home with healthcare | 0 Participants |
| Prior Therapy Arm | Discharge Location | Care facility/skilled nursing home | 0 Participants |
| Prior Therapy Arm | Discharge Location | Other | 0 Participants |
| Prior Therapy Arm | Discharge Location | Stayed in hospital for >/= 45 days | 0 Participants |
| Prior Therapy Arm | Discharge Location | Home | 0 Participants |
| Prior Therapy Arm | Discharge Location | Expired prior to discharge | 1 Participants |
Other Pre-specified
Length of Hospital Stay
Length of post-treatment hospital stay, measured in number of overnights
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in FlowTriever, Context and Prior Therapy Arms who survived to discharge or 45 days, whichever comes first.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FlowTriever Arm | Length of Hospital Stay | 7 Days |
| Context Arm | Length of Hospital Stay | 8 Days |
Other Pre-specified
Length of ICU Stay
Length of post-treatment ICU stay, measure in number of overnights
Time frame: From treatment start or ICU admission, whichever is later, to ICU discharge
Population: All patients in the FlowTriever, Context and Prior Therapy Arms who survived to discharge or study exit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FlowTriever Arm | Length of ICU Stay | 2 Days |
| Context Arm | Length of ICU Stay | 3 Days |
Other Pre-specified
Time to Extubation
Time to extubation reported as number of days
Time frame: From the time of initiation of primary treatment to extubation
Population: All patients in the FlowTriever Arm, Context Arm and Prior Therapy arm who survived to discharge or study exit, underwent a single intubation procedure prior to initiation of primary treatment, and were extubated prior to and through discharge or study exit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FlowTriever Arm | Time to Extubation | 1.640 Days |
| Context Arm | Time to Extubation | 1.795 Days |
Other Pre-specified
Use of ECMO
Frequency of ECMO use, including either pre or post treatment initiation
Time frame: From the time of primary treatment for high-risk pulmonary embolism through hospital discharge or 45 days, whichever comes first.
Population: All patients in FlowTriever, Context and Prior Therapy Arms
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FlowTriever Arm | Use of ECMO | 3 Participants |
| Context Arm | Use of ECMO | 7 Participants |
| Prior Therapy Arm | Use of ECMO | 0 Participants |