Venous Thrombosis, Venous Thrombosis Deep (Limbs)
Conditions
Keywords
Removal of Symptomatic Venous Thrombosis, Symptomatic Venous Thrombosis, Thrombosis, Thrombectomy, Blood Clot
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.
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.
Interventions
OTHERMechanical 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.
Sponsors
FlowPhysix, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | 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. |
| Safety Events will measure any risks that may occur during or after the study procedure | 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. |
| Procedure Results | Immediately after the study procedure | The number of patients that have restoration of flow in the treated vein as measured by X-ray. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vein Patency | 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. |
| Vein Disability Score | 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. |
| Villalta Score | 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. |
| Quality of Life | 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. |
Contacts
CONTACTPrasad Nalluri
CONTACTAmy Newkirk
Outcome results
None listed