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New clot-sucking device tested in real-world vein clot treatment

NCT ID NCT07708376

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 218 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.