Pulmonary Embolism
Conditions
Brief summary
The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).
Detailed description
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the FlowTriever2 Catheter for mechanical thrombectomy in patients eligible for endovascular treatment of acute pulmonary embolism (PE). The subjects who meet the inclusion/exclusion criteria will be enrolled in the study. The enrollment period is over a period of approximately 12 months. All study subjects actively participate through the 30-day visit (-5 / +15 days) following treatment. Study participation includes screening, baseline, treatment, 48-hour visit, and 30-day follow-up. The study population consists of subjects that have an acute PE. Subject eligibility is determined based on data available to the Investigator at the time of enrollment. Subjects must meet all inclusion and no exclusion criteria to be eligible for the study. All subjects that complete the procedure and the follow-ups are included in the analysis.
Interventions
DEVICEFlowTriever2 Catheter
The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism via mechanical thrombectomy of thrombus in the pulmonary arteries.
Sponsors
Inari Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical signs and symptoms consistent with acute PE * PE symptom duration ≤ 14 days * CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery) * RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio) * Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids) * Stable heart rate \< 130 BPM prior to procedure * Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment. * FlowTriever2 Catheter enters the vasculature
Exclusion criteria
* Thrombolytic use within 30 days of baseline CTA * Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization * Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg * FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90% * Hematocrit \< 28% (NOTE: hematocrit required within 6 hours of index procedure) * Platelets \< 100,000/μL * Serum creatinine \> 1.8 mg/dL * INR \> 3 * Major trauma Injury Severity Score (ISS) \> 15 * Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months * Cardiovascular or pulmonary surgery within last 7 days * Actively progressing cancer * Known bleeding diathesis or coagulation disorder * Left bundle branch block * History of severe or chronic pulmonary arterial hypertension * History of chronic left heart disease with left ventricular ejection fraction ≤ 30% * History of uncompensated heart failure * History of underlying lung disease that is oxygen dependent * History of chest irradiation * History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses heparin or anticoagulants * Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated * Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot, or non-clot embolus) * Life expectancy of \< 90 days, as determined by Investigator * Female who is pregnant or nursing * Current participation in another investigational drug or device treatment study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) | Device-related mortality and device-related major bleeding components assessed through 48 hours after index procedure. Intra-procedural device or procedure-related AE component assessed until index procedure completion (index procedure: approx. 50 mins). | Incidence of adjudicated Serious Adverse Events (SAE), which is a composite of: * Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter * Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter * Intra-procedural device or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening * Pulmonary vascular injury related to FlowTriever2 Catheter * Cardiac injury related to FlowTriever2 Catheter |
| Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg) | Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes)) | Change in mean pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE | 30 days post procedure (-5 / +15 days) | Number of adjudicated symptomatic recurrences of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) |
| Secondary Safety Endpoint: Number of Patient Mortalities | 30 days post procedure (-5 / +15 days) | Number of adjudicated all-cause mortalities through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) |
| Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use | During Procedure (index procedure: approximately 50 minutes) | Number of patients who received adjunctive thrombolytic medication during the index procedure |
| Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg) | Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes)) | Change in systolic pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure |
| Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events | 30 days post procedure (-5 / +15 days) | Number of adjudicated device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days) |
Countries
United States
Participant flow
Recruitment details
All subjects presenting to the hospital/emergency department with a pulmonary embolism (PE) and meeting all eligibility requirements for enrollment in the FLARE-FT2 study.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Absolute thrombolytic contraindication with recent intracranial/spinal surgery or head trauma | 1 Participants |
| Active Cancer No | 7 Participants |
| Active Cancer Yes | 0 Participants |
| Age, Continuous | 63 years |
| BMI (kg/m^2) | 33.2 kg/m^2 |
| Current COVID-19 status COVID-19 negative | 12 Participants |
| Current COVID-19 status COVID-19 positive | 1 Participants |
| Current COVID-19 status COVID-19 status unknown | 37 Participants |
| Diabetes type Diabetes mellitus type 1 | 1 Participants |
| Diabetes type Diabetes mellitus type 2 | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height (m) | 1.75 m |
| History of cancer No | 43 Participants |
| History of cancer Yes | 7 Participants |
| History of chronic obstructive pulmonary disease (COPD) No | 46 Participants |
| History of chronic obstructive pulmonary disease (COPD) Yes | 4 Participants |
| History of congestive heart failure (CHF) No | 47 Participants |
| History of congestive heart failure (CHF) Yes | 3 Participants |
| History of coronary artery bypass graft (CABG) No | 50 Participants |
| History of coronary artery bypass graft (CABG) Yes | 0 Participants |
| History of coronary artery disease (CAD) No | 46 Participants |
| History of coronary artery disease (CAD) Yes | 4 Participants |
| History of diabetes No | 36 Participants |
| History of diabetes Yes | 14 Participants |
| History of myocardial infarction (MI) No | 48 Participants |
| History of myocardial infarction (MI) Yes | 2 Participants |
| History of pulmonary hypertension No | 48 Participants |
| History of pulmonary hypertension Yes | 2 Participants |
| History of renal disease (chronic renal insufficiency) No | 47 Participants |
| History of renal disease (chronic renal insufficiency) Yes | 3 Participants |
| History of systemic hypertension No | 22 Participants |
| History of systemic hypertension Yes | 28 Participants |
| Hypercoagulable state No | 50 Participants |
| Hypercoagulable state Yes | 0 Participants |
| On dialysis No | 3 Participants |
| On dialysis Yes | 0 Participants |
| Patent foramen ovale (PFO) / shunt No | 49 Participants |
| Patent foramen ovale (PFO) / shunt Yes | 1 Participants |
| Prior cerebrovascular accident (prior stroke/transient ischemic attack (TIA)) No | 49 Participants |
| Prior cerebrovascular accident (prior stroke/transient ischemic attack (TIA)) Yes | 1 Participants |
| Prior COVID-19 infection Not applicable | 11 Participants |
| Prior COVID-19 infection Previously recovered | 6 Participants |
| Prior COVID-19 infection Prior infection unknown | 33 Participants |
| Prior deep venous thrombosis (DVT) No | 36 Participants |
| Prior deep venous thrombosis (DVT) Yes | 14 Participants |
| Prior Pulmonary Embolism (PE) No | 42 Participants |
| Prior Pulmonary Embolism (PE) Yes | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Recent surgery type Abdomen | 1 Participants |
| Recent surgery type Neurological | 1 Participants |
| Recent surgery type Orthopedic | 2 Participants |
| Recent surgery type Other | 2 Participants |
| Recent surgery (within 30 days) No | 44 Participants |
| Recent surgery (within 30 days) Yes | 6 Participants |
| Recent trauma (within 30 days) No | 49 Participants |
| Recent trauma (within 30 days) Yes | 1 Participants |
| Relative thrombolytic contraindication Oral anticoagulation except for aspirin | 1 Condition applies to subject |
| Relative thrombolytic contraindication Therapeutic LMWH within 24 hours | 1 Condition applies to subject |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 30 Participants |
| Thrombolytic contraindication Absolute | 1 Participants |
| Thrombolytic contraindication None | 48 Participants |
| Thrombolytic contraindication Relative | 1 Participants |
| Tobacco Use Current | 12 Participants |
| Tobacco Use Never | 26 Participants |
| Tobacco Use Past | 12 Participants |
| Weight (kg) | 99.9 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 11 / 50 |
| serious Total, serious adverse events | 10 / 50 |
Outcome results
Primary
Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg)
Change in mean pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure.
Time frame: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Subjects | Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg) | -5.50 mmHg |
Primary
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE)
Incidence of adjudicated Serious Adverse Events (SAE), which is a composite of: * Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter * Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter * Intra-procedural device or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening * Pulmonary vascular injury related to FlowTriever2 Catheter * Cardiac injury related to FlowTriever2 Catheter
Time frame: Device-related mortality and device-related major bleeding components assessed through 48 hours after index procedure. Intra-procedural device or procedure-related AE component assessed until index procedure completion (index procedure: approx. 50 mins).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) | Yes | 0 Participants |
| All Subjects | Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) | No | 50 Participants |
Secondary
Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg)
Change in systolic pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure
Time frame: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Subjects | Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg) | -8.00 mmHg |
Secondary
Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use
Number of patients who received adjunctive thrombolytic medication during the index procedure
Time frame: During Procedure (index procedure: approximately 50 minutes)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use | Yes | 0 Participants |
| All Subjects | Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use | No | 50 Participants |
Secondary
Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events
Number of adjudicated device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time frame: 30 days post procedure (-5 / +15 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events | Yes | 0 Participants |
| All Subjects | Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events | No | 46 Participants |
| All Subjects | Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events | Withdrawn | 4 Participants |
Secondary
Secondary Safety Endpoint: Number of Patient Mortalities
Number of adjudicated all-cause mortalities through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time frame: 30 days post procedure (-5 / +15 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Secondary Safety Endpoint: Number of Patient Mortalities | Yes | 0 Participants |
| All Subjects | Secondary Safety Endpoint: Number of Patient Mortalities | No | 46 Participants |
| All Subjects | Secondary Safety Endpoint: Number of Patient Mortalities | Withdrawn | 4 Participants |
Secondary
Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE
Number of adjudicated symptomatic recurrences of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time frame: 30 days post procedure (-5 / +15 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE | Yes | 0 Participants |
| All Subjects | Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE | No | 46 Participants |
| All Subjects | Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE | Withdrawn | 4 Participants |