The PEERLESS Study (PEERLESS)
Pulmonary Embolism, Pulmonary Thrombo-embolism
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring PE, pulmonary embolism, thrombectomy, FlowTriever, CDT, Catheter-Directed Thrombolysis
Eligibility Criteria
Inclusion Criteria
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
- Classification of intermediate-high-risk PE by ESC Guidelines 2019, 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 elevated cardiac troponin levels
- 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
Exclusion Criteria
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)
- Subject has previously completed or withdrawn from this study
- Patient unwilling or unable to conduct the follow up visits per protocol.
Sites / Locations
- Loma Linda University HealthRecruiting
- Providence St. Joseph OrangeRecruiting
- Huntington HospitalRecruiting
- University of Colorado HospitalRecruiting
- Radiology and Imaging AssociatesRecruiting
- Baptist Health South FloridaRecruiting
- Sarasota Memorial HospitalRecruiting
- Tallahassee Memorial HospitalRecruiting
- University of South Florida Tampa General HospitalRecruiting
- Emory UniversityRecruiting
- Ascension Alexian Brothers Medical CenterRecruiting
- Advocate Christ Medical CenterRecruiting
- Ascension St. Vincent Hospital - Indianapolis
- Norton HeralthcareRecruiting
- Brigham and Women's HospitalRecruiting
- Beth Israel Deaconess Medical Center
- Ascension St. John HospitalRecruiting
- CentraCare St. Cloud HospitalRecruiting
- University of Mississippi Medical CenterRecruiting
- Saint Luke's Hospital of Kansas CityRecruiting
- Saint Louis UniversityRecruiting
- Virtua LourdesRecruiting
- Hackensack University Medical CenterRecruiting
- Northwell HealthRecruiting
- Gates Vascular InstituteRecruiting
- NewYork-Presbyterian Columbia University Irving Medical CenterRecruiting
- University of Rochester Medical CenterRecruiting
- University of North Carolina HealthRecruiting
- Novant Health New Hanover Regional Medical CenterRecruiting
- Summa Akron City HospitalRecruiting
- Mercy Health WestRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- OhioHealth Riverside Methodist HospitalRecruiting
- St. Luke's University HospitalRecruiting
- AHN Saint Vincent HospitalRecruiting
- UPMC HarrisburgRecruiting
- University of PennsylvaniaRecruiting
- Thomas Jefferson University HospitalRecruiting
- Temple University HospitalRecruiting
- Allegheny General HospitalRecruiting
- UPMC PresbyterianRecruiting
- MUSC Health University Medical CenterRecruiting
- Spartanburg Regional Healthcare SystemRecruiting
- Lexington Medical CenterRecruiting
- HCA TriStar Centennial Medical CenterRecruiting
- Ascension Saint Thomas HospitalRecruiting
- Vanderbilt University Medical CenterRecruiting
- HCA Medical City Heart and SpineRecruiting
- Houston Methodist HospitalRecruiting
- Memorial Hermann Medical CenterRecruiting
- Methodist Main HospitalRecruiting
- Sentara Norfolk General HospitalRecruiting
- Providence Sacred Heart Medical CenterRecruiting
- Ascension St. Elizabeth HospitalRecruiting
- Gundersen Health SystemRecruiting
- Aurora St. Luke's Medical CenterRecruiting
- Universtitaetsklinikum DusseldorfRecruiting
- Herzzentrum LeipzigRecruiting
- Marien Hospital Wesel GmbHRecruiting
- Inselspital - Universitätsspital BernRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Other
Randomized Controlled Trial Cohort - FlowTriever Arm
Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.