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

July 14, 2026 updated by: FlowPhysix, Inc.

Prospective, Multicenter, Registry of the FLOWRUNNER Aspiration System for Safety and Effectiveness in the Removal of Symptomatic Venous Thrombosis (FAST)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a registry to collect data from standard of care mechanical thrombectomy procedure using FLOWRUNNER Aspiration System. The FLOWRUNNER Aspiration System is a single use catheter based system indicated for the removal of fresh, soft emboli (a soft clot) and thrombi (a stationary clot) from vessels of the peripheral (in the arms and legs) and venous (blood vessels responsible for carrying deoxygenated blood back to your heart and lungs) system.

Study Type

Observational

Enrollment (Estimated)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults (≥ 18 years) undergoing venous thrombectomy with the FLOWRUNNER Aspiration System for acute or sub-acute symptomatic upper- or lower-extremity venous thrombosis.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic upper- or lower-extremity venous thrombosis
The study is an observational registry to collect data on the standard of care treatment of venous thrombosis. There is no investigational intervention. All participants will receive mechanical thrombectomy as standard of care.
Other: Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis
Participant will receive mechanical thrombectomy for venous thrombosis as standard of care. This study is an observational registry to collect data on the standard of care non investigational intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Success
Time Frame: Immediately Post Procedure
The number of patients that had a response to treatment after the standard of care mechanical thrombectomy procedure with the study device, defined as removal of thrombus (a large amount of the blood clot from the vein or artery) during the study procedure.
Immediately Post Procedure
Safety Events will measure any risks that may occur during or after the study procedure
Time Frame: Within 30 days of the study procedure
The number of patients that have serious problems after the standard of care mechanical thrombectomy procedure that could be life threatening or cause major harm.
Within 30 days of the study procedure
Procedure Results
Time Frame: Immediately after the study procedure
The number of patients that have restoration of flow in the treated vein as measured by X-ray.
Immediately after the study procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vein Patency
Time Frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
The number of patients that have vein patency as measured by duplex ultrasound or other imaging.
Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
Vein Disability Score
Time Frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure

The number of patients that have improvement in Vein Disability Score which is a clinical assessment by the physician to score how chronic venous disease affects a patient's mobility and daily functionality. A score of 0 means no symptoms and a score of 3 means severe disability.

The total score per follow up visit will be compared to baseline.
Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure
Villalta Score
Time Frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure

The number of patients that have improvement in Villalta Score which is a clinical assessment by the physician to score patient reported symptoms from a score of 0 to 3 based on severity. A score of 0 indicates absence of symptoms and a score of 3 indicates severe symptoms. The total score is the sum of all individual scores. 0-4 is no symptoms to >15 is severe symptoms.

Clinical signs will be scored by the physician or nurse after physical examination of the affected arm/leg.
Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure
Quality of Life
Time Frame: Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.
The number of patients that have an improvement of Quality of Life as measured by the EuroQol Questionnaire. It evaluates 5 dimensions of health, with 5 levels of severity for each. A score of 1 for each question is good health, a score of 5 for each question is poor health.
Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Safety Events
Time Frame: Up to 24 months after the study procedure
The number of patients that have serious adverse events (SAEs) will be evaluated.
Up to 24 months after the study procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FlowPhysix, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

November 30, 2030

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLPF079-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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