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Randomized controlled trial (RCT) of FlowTriever® vs. catheter-directed thrombolysis (CDT) in pulmonary embolism (PE)
PEERLESS Study
NCT05111613
550 Patients Randomized 1:1
Prospective, international, randomized controlled trial of FlowTriever thrombectomy versus CDT in intermediate-risk PE
550 patients (1:1 FlowTriever vs. CDT) at up to 60 sites in the United States and Europe
Up to 150 patients with absolute contraindications to thrombolytics will be enrolled into an independent non-randomized cohort and treated with the FlowTriever thrombectomy system
Primary Endpoint
Win Ratio composite at discharge (7d max):
All-cause mortality
Intracranial hemorrhage
ISTH major bleeding
Clinical deterioration and/or bailout
ICU admission and ICU length of stay (LOS)
Follow-Up
Patients are assessed at 24-hour visit, discharge, and 30-day visit
Eligible Patients:
Intermediate-Risk PE with Additional Clinical Risk Factors
YES
NO
Absolute contraindication to thrombolytics?
RCT Cohort Randomized 1:1, stratified by VTE-BLEED
Indications for Use:
The FlowTriever retrieval/aspiration system is indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. The FlowTriever retrieval/aspiration system is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever catheters are indicated for (1) the non-surgical removal of emboli and thrombi from blood vessels and (2) injection, infusion and/or aspiration of contrast media and other fluids into or from a blood vessel. Triever catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever catheters are also intended for use in treating clot in transit in the right atrium but not in conjunction with the FlowTriever catheters.
Refer to IFU for complete Indications for Use, contraindications, warnings, and precautions.
Caution:
Federal (USA) law restricts this device to sale distribution and use by or on order of a physician.
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