RecruitingNot Applicable

The PEERLESS II Study

United States1,200 participantsStarted 2023-11-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. At least two additional risk factors, identified by at least one measure in two separate categories noted below:
✓. Symptom onset within 14 days of confirmed PE diagnosis
✓. Willing and able to provide informed consent

Exclusion criteria

✕. 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
✕. Systolic BP \< 90 mmHg or systolic BP drop ≥ 40 mmHg, lasting longer than 15 min and not caused by new-onset arrhythmia, hypovolemia, or sepsis \* Patients who are stable at time of screening or randomization (i.e., SBP ≥ 90 mmHg and adequate organ perfusion without catecholamine or vasopressor infusion) may be included despite initial presentation including temporary, low-dose catecholamines or vasopressors, or temporary fluid resuscitation.
✕. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
✕. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention (e.g., inability to navigate to target location, clot limited to segmental/subsegmental distribution, predominately chronic clot)
✕. End stage medical condition with life expectancy \< 3 months, as determined by the Investigator

What they're measuring

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

Timeframe: through discharge or 30 days, whichever is sooner / dyspnea at 48 hours

Trial details

NCT IDNCT06055920

SponsorInari Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Stephanie Gourley

580-400-2590 stephanie.gourley@inarimedical.com

View on ClinicalTrials.gov More Pulmonary Embolism trials