Design
200 patients randomized 1:1
- Prospective, international, randomized controlled trial of FlowTriever large-bore mechanical thrombectomy versus standard of care (SoC)
- ~200 patients (1:1 FlowTriever vs. SoC) at up to 40 sites in Europe and the US
Primary endpoint
Composite of events through earlier of initial hospital discharge or 7 days
- All-cause mortality
- Cardiac arrest with loss of consciousness requiring CPR
- Bailout to alternative therapeutic strategy
- Major bleeding**
- Persistent need for ECMO
Follow-up
- After treatment, patients are assessed at a 72-hour visit, the earlier of initial hospital discharge or 7 days post randomization, a 1-month visit, and a 3-month visit
*Standard of Care anticoagulation therapy with or without interventional treatment, including systemic thrombolysis
**Per Bleeding Academic Research Consortium (BARC) types 3b, 3c, 5a and 5b
References
Chopard R, Hobohm L, Barco S, Bangalore S, Giri J, Mahfoud F, Moriarty J, Rosenkranz S, Sharp A, Thiele H, Toma C, Tapson VF, Markovitz CD, Rosenberg SP, Konstantinides S, Meneveau N. Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial. Am Heart J. 2026 Apr;294:107331. doi: 10.1016/j.ahj.2025.107331. Epub 2025 Dec 24.
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-4510-USA-EN-v1