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

Starting soon

Conditions studied: Venous Thrombosis Deep (Limbs), Venous Thrombosis

In brief

The objective of this study is to evaluate how well and how safe the FLOWRUNNER Aspiration System works for treating blood clots in the arms or legs in real-life medical settings.

Key facts

Study ID

NCT07708376

Run by

FlowPhysix, Inc.

People needed

218

Starts

2026-08-31

Expected to finish

2030-11-30

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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:
• Hemodynamic instability (e.g., sustained hypotension, shock, or cardiac arrest)
• Requirement for thrombolytic therapy or surgical embolectomy
• Any condition that, in the investigator's judgment, would pose an unacceptable risk for participation in the study
• 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:
• Tumor-associated venous thrombosis, defined as: venous thrombosis occurring in the context of active malignancy or cancer-related hypercoagulability
• Presence of metastatic disease or ongoing chemotherapy
• Known antiphospholipid syndrome or other high-risk coagulation disorders, including:
• Confirmed diagnosis of antiphospholipid antibody syndrome
• Severe inherited or acquired thrombophilia (e.g., protein C or S deficiency, antithrombin deficiency)
• Any coagulation disorder that, in the investigator's judgment, would pose an unacceptable risk for thrombectomy or confound study outcomes
• Estimated life expectancy of less than 12 months, based on the investigator's clinical judgement, available medical history, and prognostic indicators.
• Chronic non-ambulatory status, defined as:
• Persistent inability to walk or perform basic mobility activities due to underlying medical conditions
• Conditions such as advanced neurological disease, severe musculoskeletal impairment, or long-term paralysis
• Contraindicated for intravascular therapy including:
• Active bleeding
• Severe anemia with hemoglobin (Hb) < 8 g/dL
• High risk of bleeding
• History of heparin allergy/hypersensitivity or heparin-induced thrombocytopenia
• Hypersensitivity to contrast agents

Full record on ClinicalTrials.gov

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