PE - Pulmonary Embolism, PE - Pulmonary Thromboembolism
Conditions
Keywords
PE, pulmonary embolism, thromboembolism, thrombectomy, FlowTriever, Anticoagulation Medication
Brief summary
To evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice. Up to 300 additional patients with anticoagulation treatment as the initial planned primary treatment strategy for intermediate risk PE will also be evaluated (US only).
Interventions
DEVICEFlowTriever System
Thrombectomy
Anticoagulation medication
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
* Clinical signs and symptoms consistent with acute PE * Echo, CTPA or pulmonary angiographic evidence of proximal filling defect in at least one main or lobar pulmonary artery * Scheduled for PE treatment with the FlowTriever System per the Investigator's discretion\* * US only: Patients enrolled in the Conservative Therapy Sub-study are not required to meet this inclusion criteria but must instead be scheduled for primary anticoagulation therapy as the primary treatment strategy.
Exclusion criteria
* Unable to be anticoagulated with heparin or alternative * Diagnosis with a minor PE with a less than 0.9 RV/LV ratio * Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated\* * Imaging evidence or other evidence that suggests, in the Investigator's opinion, the subject is not appropriate for mechanical thrombectomy intervention\* * Life expectancy \< 30 days, as determined by Investigator * Current participation in another investigational drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study * US Only Patients enrolled in the Conservative Therapy Sub-study are not required to meet these
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With Major Adverse Events | 48-hours after index procedure | MAEs are defined as a composite, when one or more of the following events occur: * Device-related mortality through 48 hours after the index procedure, or * Major bleeding through 48 hours after the index procedure, or * Intra-procedural device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device-Related Mortality | 48-hours after the index procedure | Rate of subjects with device related mortality through 48 hours post index procedure |
| Major Bleeding | 48 hours after index procedure | Rate of subjects with major bleeding through 48 hours after the index procedure (fatal bleeding; symptomatic bleeding in a critical area or organ; bleeding causing a fall in hemoglobin of ≥5 g/dL or leading to transfusion of 2 or more units of blood products) |
| Intraprocedural Device-related or Procedure-related Adverse Events | Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient. | Intraprocedural Device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury. |
Countries
Austria, Belgium, France, Germany, Netherlands, Spain, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FlowTriever Mechanical thrombectomy for pulmonary embolism
FlowTriever System: Thrombectomy | 999 |
| Total | 999 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 45 |
| Overall Study | Lost to Follow-up | 93 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 74 |
| Overall Study | Withdrawal for Other Reasons | 29 |
Baseline characteristics
| Characteristic | FlowTriever |
|---|---|
| Active Cancer No | 116 Participants |
| Active Cancer Yes | 94 Participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 451 Participants |
| Age, Categorical Between 18 and 65 years | 547 Participants |
| Age, Continuous | 61.6 years STANDARD_DEVIATION 14.3 |
| BMI (kg/m^2) | 33.8 kg/m^2 STANDARD_DEVIATION 8.1 |
| Concomitant DVT No | 368 Participants |
| Concomitant DVT Yes | 621 Participants |
| DVT Location Both | 96 Participants |
| DVT Location Distal Only | 308 Participants |
| DVT Location Proximal Only | 209 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 698 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 281 Participants |
| History of Cancer No | 789 Participants |
| History of Cancer Yes | 210 Participants |
| Lytic Contraindication No | 695 Participants |
| Lytic Contraindication Yes | 303 Participants |
| PE Classification High Risk | 143 Participants |
| PE Classification Intermediate-High Risk | 718 Participants |
| PE Classification Intermediate-Low Risk | 65 Participants |
| PE Classification Intermediate Risk, Not Further Classified | 71 Participants |
| Prior History of DVT No | 811 Participants |
| Prior History of DVT Yes | 187 Participants |
| Prior History of PE No | 898 Participants |
| Prior History of PE Yes | 101 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 192 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 227 Participants |
| Race (NIH/OMB) White | 572 Participants |
| Sex: Female, Male Female | 453 Participants |
| Sex: Female, Male Male | 546 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 45 / 999 |
| other Total, other adverse events | 0 / 999 |
| serious Total, serious adverse events | 125 / 999 |
Outcome results
Primary
Subjects With Major Adverse Events
MAEs are defined as a composite, when one or more of the following events occur: * Device-related mortality through 48 hours after the index procedure, or * Major bleeding through 48 hours after the index procedure, or * Intra-procedural device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury The components of the composite MAE endpoint were adjudicated by the independent Medical Monitor.
Time frame: 48-hours after index procedure
Population: Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 11 subjects, yielding 988 analyzed subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FlowTriever | Subjects With Major Adverse Events | Yes | 24 Participants |
| FlowTriever | Subjects With Major Adverse Events | No | 964 Participants |
Secondary
Device-Related Mortality
Rate of subjects with device related mortality through 48 hours post index procedure
Time frame: 48-hours after the index procedure
Population: Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 13 subjects, yielding 986 analyzed subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FlowTriever | Device-Related Mortality | Yes | 0 Participants |
| FlowTriever | Device-Related Mortality | No | 986 Participants |
Secondary
Intraprocedural Device-related or Procedure-related Adverse Events
Intraprocedural Device-related or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening, or * Device-related pulmonary vascular injury, or * Device-related cardiac injury.
Time frame: Intraprocedural - occurring during the procedure or within 30 minutes of the FlowTriever Catheter being removed from the patient.
Population: Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 12 subjects, yielding 987 analyzed subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FlowTriever | Intraprocedural Device-related or Procedure-related Adverse Events | Yes | 8 Participants |
| FlowTriever | Intraprocedural Device-related or Procedure-related Adverse Events | No | 979 Participants |
Secondary
Major Bleeding
Rate of subjects with major bleeding through 48 hours after the index procedure (fatal bleeding; symptomatic bleeding in a critical area or organ; bleeding causing a fall in hemoglobin of ≥5 g/dL or leading to transfusion of 2 or more units of blood products)
Time frame: 48 hours after index procedure
Population: Full Analysis Population - all subjects who enrolled in the FLASH Study and met the inclusion and exclusion criteria. Outcome was not evaluable for 12 subjects, yielding 987 analyzed subjects.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FlowTriever | Major Bleeding | Yes | 17 Participants |
| FlowTriever | Major Bleeding | No | 970 Participants |