The PEERLESS II Study
ConditionPulmonary Embolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInari Medical
About this trial
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 criteria
Qualifiers
Age at enrollment ≥ 18 years
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
RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis
Symptom onset within 14 days of confirmed PE diagnosis
Disqualifiers
Unable to be anticoagulated with heparin, enoxaparin or other parenteral antithrombin
Presentation with hemodynamic instability* that meets the high-risk PE definition in the 2019 ESC Guidelines1, including ANY of the following
Cardiac arrest OR
Systolic BP < 90 mmHg or vasopressors required to achieve a BP ≥ 90 mmHg despite adequate filling status, AND end-organ hypoperfusion OR
Trial design
Treatments tested in this trial
- FlowTriever System
- Anticoagulation Agents
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov