Pulmonary embolism
Conditions
Interventions
None listed
Sponsors
Inari Medical Europe GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must meet each of the following criteria to be included in the study: 1. Age * 18 years 2. Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery 3. Classification of intermediate-high-risk PE by ESC Guidelines 20191, including ALL of the following: a. Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI *1 AND b. Hemodynamically stable AND c. RV dysfunction on echocardiography or CT AND d. Elevated cardiac troponin levels 4. Intervention planned to begin within 72 hours of the later of either a. Confirmed PE diagnosis OR b. If transferring from another hospital, arrival at the treating hospital 5. Symptom onset within 14 days of confirmed PE diagnosis
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study for any of the following criteria: 1. Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin 2. Index presentation with hemodynamic instability that are part of the high- risk PE definition in the ESC Guidelines 20191, including ANY of the following: a. Cardiac arrest OR b. Systolic BP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite clinical endpoint constructed as a win ratio, a hierarchy of the following, assessed at hospital discharge or at 7 days after the index procedure, whichever is sooner: 1. All-cause mortality, or 2. Intracranial hemorrhage (ICH), or 3. Major bleeding per ISTH definition4, or 4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or 5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of the study will assess safety, effectiveness, and utility measures, as follows: * Composite clinical endpoint constructed as a win ratio hierarchy of the following four components, assessed at hospital discharge or at 7 days after the index procedure, whichever is sooner: o All-cause mortality, or o Intracranial hemorrhage (ICH), or o Major bleeding per ISTH definition4, or o Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy * Individual components of the win ratio composite endpoint, assessed at hospital discharge or at 7 days after the index procedure, whichever is sooner: o All-cause mortality o Intracranial hemorrhage (ICH) o Major bleeding per ISTH4 definition o Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy o ICU admission and ICU length of stay during the index hospitalization and following the index procedure * All-cause mortality within 30 days from index procedure * PE-related and all-cause readmission within 30 days from index procedure * Device and drug-related serious adverse events through the 30 day visit * Clinically Relevant Non-Major (CRNM) and Minor bleeding events through hospital discharge or at 7 days after the index procedure, whichever is sooner * Change in right-ventricular/left-ventricular (RV/LV) ratio from baseline to 24 hour visit, as measured by echocardiography or CT * mMRC Dyspnea score at 24 hour visit and 30 day visit * Length of total hospital stay and post-index-procedure hospital stay (to a maximum of 30 days) * Disease-specific and general health-related quality of life at the 30 day visit (PEmb-QoL and EQ-5D-5L) | — |
Countries
Netherlands
Outcome results
None listed