Design
Up to 1200 patients randomized 1:1
- Prospective, international, randomized controlled trial of FlowTriever thrombectomy versus anticoagulation alone in intermediate-risk PE
- Up to 1200 patients (1:1 FlowTriever vs. anticoagulation alone) at up to 100 global sites
Primary endpoint
Hierarchical win ratio composite
- All-cause mortality by 30 days
- Clinical deterioration through discharge or up to 30 days
- All-cause hospital readmission by 30 days
- Bailout therapy through discharge or up to 30 days
- Dyspnea at 48-hour visit
Follow-up
- Patients are assessed at baseline visit, 48-hour visit, discharge, 1-month visit, and 3-month visit
Reference
Giri et al. PEERLESS II: A Randomized Controlled Trial of Large-Bore Thrombectomy Versus Anticoagulation in Intermediate-Risk Pulmonary Embolism. J Soc Cardiovasc Angiogr Interv. 2024 May 3;3(6):101982
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 intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever catheters. The Triever20 Curve is used coaxially within the Triever24 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 Triever20 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever20 Curve catheter is not indicated for use with FlowTriever catheters. Triever20 Curve is also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever catheters. Triever20 Curve must be used within the Triever24. The FlowSaver blood return system is used with Triever catheters for autologous blood transfusion. The Triever16 Curve 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 Triever16 Curve is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. The Triever16 Curve is not indicated for use with FlowTriever catheters. The Triever16 Curve is also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever catheters.
Review complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and contraindications prior to use of the product.
For all non-Stryker products, please refer to manufacturer Instructions for Use/Intended Purpose for complete indications for use, contraindications, warnings and precautions.
Caution
Federal (USA) law restricts this device to sale by or on the order of a physician.
PRO-4509-USA-EN-v1