A Registry of the FLOWRUNNER Aspiration System for Patients With Symptomatic Venous Thrombosis

Exclusion criteria

• . Evidence of a chronic or previously undiagnosed extensive clot on the pre-procedure venogram that makes endovascular thrombectomy inappropriate. Indicators of chronic clot include significant venous narrowing, the presence of diffuse collateral vessels, partial recanalization, Inferior Vena Cava (IVC) hyperplasia, or other congenital anatomic anomalies of the IVC, iliac veins, or subclavian veins.
• . No available upper- or lower-extremity venous access site suitable for the procedure due to absence of appropriate access, severe anatomical obstruction, scarring, or prior surgical alteration that prevents safe catheter insertion or any condition that, in the investigator's judgement, makes upper- or lower-extremity venous access technically infeasible or unsafe.
• . Pregnant or breastfeeding at the time of enrollment.
• . High-risk for pulmonary embolism (PE), defined as those presenting with:
• . Presents with cardiogenic shock or is hemodynamically unstable.
• . Any prior or current cancer diagnosis that, in the investigator's judgment, would pose an unacceptable risk or confound study outcomes including but not limited to:
• . Known antiphospholipid syndrome or other high-risk coagulation disorders, including:
• . Estimated life expectancy of less than 12 months, based on the investigator's clinical judgement, available medical history, and prognostic indicators.