Pulmonary Embolism
Conditions
Keywords
Pulmonary Embolism, eTrieve
Brief summary
Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism
Interventions
DEVICEeTrieve PE Kit
Patients will be treated with the eTrieve PE Kit
Sponsors
Magneto Thrombectomy Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE) * PE symptom duration ≤ 14 days * Filling defect in at least one main or lobar pulmonary artery on CTA * Right ventricle / left ventricle (RV/LV) ratio ≥ 0.9 on CTA (Investigator's reading) * Systolic blood pressure ≥ 90 mmHg * Stable heart rate \< 130 BPM prior to the index procedure * Anatomy that, in the opinion of the interventionalist, allows safe passage of the eTrieve™ catheters * Written informed consent
Exclusion criteria
* Patients with a combined reason for their decompensation (e.g., a patient with both sepsis and PE) * PE within 3 months prior to screening assessment * Thrombolytic use within 30 days prior to baseline CTA * Pulmonary hypertension with peak systolic PAP \> 70 mmHg * Inotrope or vasopressor requirement after fluid administration to keep the systolic blood pressure ≥ 90 mmHg * Fraction of inspired Oxygen (FiO2) requirement \> 40% or supplemental oxygen \> 6 LPM to keep oxygen saturation \> 90% * Any of the following laboratory findings (within 6 hours prior to index procedure): 1. Hematocrit \< 28% 2. Platelets \< 100,000/µL 3. Serum creatinine \> 1.8 mg/dL 4. INR \> 3 * Major trauma Injury Severity Score (ISS) \> 15 within 14 days prior to screening assessment * Intracardiac lead in right ventricle, right atrium or coronary sinus, placed within 6 months prior to screening assessment * Known presence of intracardiac clot * Cardiovascular or pulmonary surgery within last 7 days * Active malignancy and / or on chemotherapy * Known bleeding diathesis or coagulation disorder * Left bundle branch block * History of severe or chronic pulmonary arterial hypertension * History of left ventricular ejection fraction ≤ 30% * History of decompensated heart failure * History of underlying oxygen dependent lung disease * History of chest irradiation * History of Heparin Induced Thrombocytopenia (HIT) * Any contraindication to systemic therapeutic doses of heparin or other anticoagulants * Known anaphylactic reaction to radiographic contrast agents that cannot be adequately pre-medicated * Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically * Imaging evidence or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention * Life expectancy of \< 90 days as determined by the investigator * Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study * Female who is pregnant or nursing * Current participation in another investigational drug or device treatment study * Previous enrollment in the eTrieve™ II Study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAE | 48 hours | Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC) |
| RV/LV ratio | 48 hours | Change in RV/LV ratio from baseline to 48 hours post-index procedure (or discharge, whichever occurs first) as assessed by the CTA core laboratory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Miller score | at 48 hours | Change in the Modified Miller Score between baseline and 48 hours post-index procedure as assessed by the CTA core laboratory |
| Mortality | within 30 days | Mortality due to any cause within 30 days post-index procedure |
| Use of thrombolytics | within 48 hours | Use of thrombolytics within 48 hours post-index procedure |
| PE reocurrence | within 30 days | Symptomatic PE recurrence within 30 days post-index procedure |
| Device related SAE | within 30 days | Device-related serious adverse events within 30 days post-index procedure, as adjudicated by the CEC |
| ICU/hospitalization length | within 30 days | Length of stay in the Intensive Care Unit (ICU)/hospital, associated with the index thrombectomy procedure |
Contacts
Primary ContactTami Abudi
Outcome results
None listed