PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism
Inari Medical
Summary
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age at enrollment ≥ 18 years 2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery, as confirmed by CTPA, pulmonary angiography, or other imaging modality 3. RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis 4. At least two additional risk factors, identified by at least one measure in two separate categories noted below: a. Hemodynamic: i. SBP 90-100mmHg ii. Resting heart rate \> 100 bpm b. Biomarker: i. Elevated\* cardiac troponin (troponin I or troponin T, conven…