The PEERLESS Study

Inari Medical

Status: Completed

Conditions: Pulmonary Embolism; Pulmonary Thrombo-embolism

Treatments: Device: FlowTriever System; Device: Catheter-Directed Thrombolysis

Study type: Interventional

Funder types: Industry

Identifiers

NCT05111613

21-002

Details and patient eligibility

About

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.

Enrollment: 692 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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692 participants in 3 patient groups

Randomized Controlled Trial Cohort - FlowTriever Arm

Active Comparator group

Description:

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Treatment:

Device: FlowTriever System

Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm

Active Comparator group

Description:

Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)

Treatment:

Device: Catheter-Directed Thrombolysis

Non-Randomized Absolute Contraindication to Thrombolytics Cohort

Other group

Description:

Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.

Treatment:

Device: FlowTriever System