PEERLESS Study

Germany, Netherlands, Switzerland, United States (ICTRP)

ICTRP Trial ID
NCT05111613 (ICTRP)

Official title (approved by ethics committee)
PEERLESS study, 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. (BASEC)

Academic title
The PEERLESS Study (ICTRP)

Public title
The PEERLESS Study (ICTRP)

Disease under investigation
Pulmonary EmbolismPulmonary Thrombo-embolism (ICTRP)

Intervention under investigation
Device: Catheter-Directed ThrombolysisDevice: FlowTriever System (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion 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

- 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

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). 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. (ICTRP)

not available

Primary and secondary end points
Composite clinical endpoint constructed as a win ratio, a hierarchy of the following: (ICTRP)

Composite clinical endpoint constructed as a win ratio hierarchy of the following four components:;All-cause mortality;Intracranial hemorrhage (ICH);Major bleeding per ISTH definition;Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy;ICU admission and ICU length of stay during the index hospitalization and following the index procedure;All cause mortality;PE-related and all-cause readmission;Device and drug-related serious adverse events;Clinically Relevant Non-Major (CRNM) and Minor bleeding events;Change in right-ventricular/left-ventricular (RV/LV) ratio, as measured by echocardiography or CT;Modified Medical Research Council (mMRC) dyspnea score;Length of total hospital stay and post-index-procedure hospital stay;Pulmonary Embolism Quality of Life (PEmb-QOL);EQ-5D-5L Quality of Life (ICTRP)

Registration date
15.10.2021 (ICTRP)

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Wissam Jaber, MD;Carin Gonsalves, MD;Stefan Stortecky, MD, Emory University,Thomas Jefferson University,Bern University Hospital (ICTRP)

Secondary trial IDs
21-002 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05111613 (ICTRP)