The PEERLESS Study
Purpose
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.
Conditions
- Pulmonary Embolism
- Pulmonary Thrombo-embolism
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Randomized Controlled Trial Cohort - FlowTriever Arm |
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System. |
|
Active Comparator Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm |
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system) |
|
Other Non-Randomized Absolute Contraindication to Thrombolytics Cohort |
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System. |
|
Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Inari Medical