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

NCT07708376 | Not Yet Recruiting FDA Device

• 1 other identifier: CLPF079-01
• Study Type: observational
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Venous Thrombosis Deep (Limbs); Venous Thrombosis

Keywords

Removal of Symptomatic Venous Thrombosis; Symptomatic Venous Thrombosis; Thrombosis; Thrombectomy; Blood Clot

Outcome Measures

Primary Outcomes (3)

• Procedure Success

  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

  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

  The number of patients that have restoration of flow in the treated vein as measured by X-ray.

  Immediately after the study procedure

Secondary Outcomes (4)

• Vein Patency

  Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.

• Vein Disability Score

  Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure

• Villalta Score

  Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure

• Quality of Life

  Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.

Other Outcomes (1)

• Additional Safety Events

  Up to 24 months after the study procedure

Study Arms (1)

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

Interventions

Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis OTHER

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.

Symptomatic upper- or lower-extremity venous thrombosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• FlowPhysix, Inc.: lead

Related Publications (21)

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MeSH Terms

Conditions

Venous Thrombosis; Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Prasad Nalluri

CONTACT

210-355-9512; prasad.nalluri@flowphysix.com

Amy Newkirk

CONTACT

831-239-6711; amy.newkirk@flowphysix.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): November 30, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07