New clot-sucking device tested in real-world vein clot treatment
NCT ID NCT07708376
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study tracks how well the FLOWRUNNER Aspiration System removes symptomatic blood clots from veins in the arms or legs during routine care. About 218 adults with deep-vein clots will be followed to see if the device safely restores blood flow and reduces clot-related disability. The goal is to measure real-world effectiveness and safety outside of a controlled trial setting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a mechanical thrombectomy device called the FLOWRUNNER Aspiration System, which suctions out blood clots
- What this could lead to
- If successful, this registry could confirm that the FLOWRUNNER system is a safe and effective tool for removing symptomatic venous clots in routine care.
- What could go wrong
- This is an observational registry, not a randomized trial, so results may be influenced by patient selection and lack a control group. The device may still carry risks like bleeding or vessel damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 218 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults (≥ 18 years) undergoing venous thrombectomy with the FLOWRUNNER Aspiration System for acute or sub-acute symptomatic upper- or lower-extremity venous thrombosis.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Eligibility Criteria: 1. Adults ≥ 18 years of age. 2. Symptomatic upper- or lower-extremity venous thrombosis. 3. Treatment with the FLOWRUNNER Aspiration System for venous thrombectomy as part of routine care. 4. Willing to participate, able to understand and able to voluntarily sign the Informed Consent Form (ICF) prior to the initial qualifying procedure (index procedure). 5. Willing and able to participate and comply with all protocol-required follow-up visits and assessments. Exclusion Criteria: 1. 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. 2. 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. 3. Pregnant or breastfeeding at the time of enrollment. 4. 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 5. Presents with cardiogenic shock or is hemodynamically unstable. 6. 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 7. 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 8. Estimated life expectancy of less than 12 months, based on the investigator's clinical judgement, available medical history, and prognostic indicators. 9. 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 10. 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 * Contraindication to oral/intravenous anticoagulation * Hypercoagulable risk * Any other condition that cannot be effectively managed 11. Renal dysfunction (eGFR \< 30 mL/min/1.73m2, not yet on dialysis). 12. Cerebral or myocardial infarction in the last 3 months. 13. Any condition that, in the investigator's judgment, would pose unacceptable risk or interfere with study participation, including: * Severe allergy to contrast media * Active systemic infection * Uncontrolled coagulopathy * Phlegmasia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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