The PEERLESS Study (NCT05111613) | Clinical Trial Compass
CompletedNot Applicable
The PEERLESS Study
United States692 participantsStarted 2022-02-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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-or…
What they're measuring
1
Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio
Timeframe: Hospital discharge or at 7 days after the index procedure, whichever is sooner