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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • FlowTriever System

    Device

    Mechanical Thrombectomy for pulmonary embolism

  • Anticoagulation Agents

    Drug

    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.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: FlowTrieverActive comparator 1 intervention
Group B: AnticoagulationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite clinical endpoint constructed as a win ratio, a hierarchy of the following, which are assessed post-randomization:

* All-cause mortality by 30 days, or * Clinical deterioration, defined by hemodynamic or respiratory worsening, through discharge or up to 30 days after randomization, whichever is sooner, or * All-cause hospital re-admission by 30 days, or * Bailout therapy, either after a deterioration or after documented failure to progress, through discharge or up to 30 days after randomization, whichever is sooner, or * Change in Dyspnea, by mMRC from Baseline to the 48-hour visit

Time frame
through discharge or 30 days, whichever is sooner / dyspnea at 48 hours

Secondary outcomes

1

Composite clinical endpoint constructed as a win ratio hierarchy of the following three components, assessed post randomization:

* All-cause mortality, by 30 days, or * Clinical deterioration defined by hemodynamic or respiratory worsening, through discharge or up to 30 days after randomization, whichever is sooner, or * All-cause readmission, by 30 days

Time frame
up to 30 days
2

All-cause and PE-related mortality

Time frame
At 30 and 90 days
3

All-cause and PE-related readmissions

Time frame
At 30 and 90 days
4

Clinical deterioration

defined by hemodynamic or respiratory worsening

Time frame
Through discharge or up to 30 days after randomization, whichever is sooner

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inari Medical

Lead sponsor

Source ClinicalTrials.gov
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