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…
Interventions
- DeviceFlowTriever System
Mechanical Thrombectomy for pulmonary embolism
- DrugAnticoagulation Agents
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc. Anticoagulants are a group of medications that decrease your blood's ability to clot.
Locations (83)
- UAB Division of Cardiovascular DiseaseBirmingham, Alabama
- Brookwood Medical CenterBirmingham, Alabama
- Huntington Memorial HospitalPasadena, California
- University of Colorado, DenverAurora, Colorado
- Yale UniversityNew Haven, Connecticut
- HCA FL Largo Medical CenterLargo, Florida