Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism, Massive Pulmonary Embolism
Conditions
Keywords
Thromboembolism, Thrombectomy, Right Heart Strain, Submassive PE, Right Ventricle Dysfunction, Massive PE
Brief summary
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.
Interventions
DEVICEFlowTriever System
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, symptoms and presentation consistent with acute PE * PE symptom duration ≤ 14 days * CTA evidence of proximal PE * RV/LV ratio ≥ 0.9 without syncope * Systolic BP ≥ 90 mmHg * Stable heart rate \<130 BPM prior to procedure * Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment
Exclusion criteria
* Thrombolytic use within 30 days of baseline CTA * Pulmonary hypertension with peak PAP \> 70 mmHg by right heart catheterization * Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg * FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90% * Hematocrit \< 28% within 6 hours of index procedure * Platelets \< 100,000/µL * Serum creatinine \> 1.8 mg/dL * INR \> 3 * Major trauma ISS \> 15 * Presence of intracardiac lead in right ventricle or 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 * Any contraindication to systemic or therapeutic doses of heparin or anticoagulants * Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated * Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention * Life expectancy of \< 90 days * Female who is pregnant or nursing * Current participation in another investigational drug or device treatment study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in RV/LV Ratio | Baseline to 48 hours | Change in RV/LV ratio from baseline to 48 hours |
| Number of Participants With Major Adverse Events | Within 48 hours | Device-related death, major bleeding, and treatment related AEs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FlowTriever System FlowTriever System | 104 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death from undiagnosed breast cancer through 30-day follow-up | 1 |
| Overall Study | Received adjunctive thrombolytics | 2 |
Baseline characteristics
| Characteristic | FlowTriever System |
|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Pre-procedural RV/LV ratio | 1.56 ratio STANDARD_DEVIATION 0.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 86 Participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 106 |
| other Total, other adverse events | 0 / 106 |
| serious Total, serious adverse events | 14 / 106 |
Outcome results
Primary
Change in RV/LV Ratio
Change in RV/LV ratio from baseline to 48 hours
Time frame: Baseline to 48 hours
Population: Patients with symptomatic, computed tomography-documented PE and RV/LV ratios ≥ 0.9 treated with the FlowTriever System that were not administered thrombolytic agents during the index procedure (n = 104)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FlowTriever System | Change in RV/LV Ratio | 0.38 RV/LV ratio | Standard Error 0.03 |
p-value: <0.0001t-test, 1 sided
Primary
Number of Participants With Major Adverse Events
Device-related death, major bleeding, and treatment related AEs
Time frame: Within 48 hours
Population: Patients with symptomatic, computed tomography-documented PE and RV/LV ratios ≥ 0.9 treated with the FlowTriever System that were not administered thrombolytic agents during the index procedure (n = 104)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FlowTriever System | Number of Participants With Major Adverse Events | Participants experiencing MAEs | 4 Participants |
| FlowTriever System | Number of Participants With Major Adverse Events | Participants not experiencing MAEs | 100 Participants |
p-value: <0.0001t-test, 1 sided