The PEERLESS Study

Completed · Not applicable

Conditions studied: Pulmonary Embolism, Pulmonary Thromboembolism

In brief

A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.

Key facts

Study ID: NCT05111613
Run by: Inari Medical
People needed: 692
Starts: 2022-02-14
Expected to finish: 2024-04-11
Last updated by the study team: 2025-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet each of the following criteria to be included in the study:
Age ≥ 18 years
Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery
Including ALL of the following: Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND Hemodynamically stable AND; RV dysfunction on echocardiography or CT; AND Any one or more of the following present at the time of diagnosis: Elevated cardiac troponin levels; History of heart failure; History of chronic lung disease; Heart rate ≥110 beats per minute; SBP <100mmHg; Respiratory rate ≥30 breaths per minute; O2 saturation <90%; Syncope related to PE; Elevated Lactate
Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital
Symptom onset within 14 days of confirmed PE diagnosis

You may not qualify if…

Subjects will be excluded from the study for any of the following criteria:
Unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin
Index presentation with hemodynamic instability that are part of the high-risk PE definition in the ESC Guidelines 2019, 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
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)
Patient has right heart clot in transit identified at baseline screening
Life expectancy < 30 days (e.g. stage 4 cancer or severe COVID-19 infection), as determined by the Investigator
Current participation in another drug or device study that, in the Investigator's opinion, would interfere with participation in this study
Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis, per ESC 2019 guidelines
Invasive systolic PA pressure ≥70 mmHg prior to study device entering the body
Administration of bolus or drip/infusion thrombolytic therapy or mechanical thrombectomy for the index PE event within 48 hours prior to enrollment
Ventricular arrhythmias refractory to treatment at the time of enrollment
Known to have heparin-induced thrombocytopenia (HIT)
Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments). This includes a contraindication to use of FlowTriever or CDT System (for example, EKOS System) per local approved labeling
Subject has previously completed or withdrawn from this study
Patient unwilling or unable to conduct the follow up visits per protocol.

Where it is running

Providence St. Joseph Orange — Orange, California, United States
Huntington Hospital — Pasadena, California, United States
University of Colorado Hospital — Aurora, Colorado, United States
Radiology and Imaging Associates — Lakeland, Florida, United States
Baptist Health South Florida — Miami, Florida, United States
Sarasota Memorial Hospital — Sarasota, Florida, United States
Tallahassee Memorial Hospital — Tallahassee, Florida, United States
University of South Florida Tampa General Hospital — Tampa, Florida, United States
Emory University — Atlanta, Georgia, United States
Ascension Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
Advocate Christ Medical Center — Oak Lawn, Illinois, United States
Ascension St. Vincent Hospital - Indianapolis — Indianapolis, Indiana, United States
Norton Healthcare — Louisville, Kentucky, United States
Brigham and Womens Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Ascension St. John Hospital — Detroit, Michigan, United States
CentraCare St. Cloud Hospital — Saint Cloud, Minnesota, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
Saint Louis University — St Louis, Missouri, United States
Virtua Lourdes — Camden, New Jersey, United States
Hackensack University Medical Center — Hackensack, New Jersey, United States
Northwell Health — Bay Shore, New York, United States
Gates Vascular Institute — Buffalo, New York, United States
Loma Linda University Health — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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