A Registry of the FLOWRUNNER Aspiration System for Patients With Symptomatic Venous Thrombosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFlowPhysix, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥ 18 years of age.
Symptomatic upper- or lower-extremity venous thrombosis.
Treatment with the FLOWRUNNER Aspiration System for venous thrombectomy as part of routine care.
Willing to participate, able to understand and able to voluntarily sign the Informed Consent Form (ICF) prior to the initial qualifying procedure (index procedure).
Disqualifiers
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.
Hemodynamic instability (e.g., sustained hypotension, shock, or cardiac arrest)
Trial population
Adults (≥ 18 years) undergoing venous thrombectomy with the FLOWRUNNER Aspiration System for acute or sub-acute symptomatic upper- or lower-extremity venous thrombosis.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis
Other interventionParticipant 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.
Treatment groups
218 Participants
are divided into 1 treatment groupGroup A: Symptomatic upper- or lower-extremity venous thrombosis1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately Post Procedure2
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.
Time frame
Within 30 days of the study procedure3
Procedure Results
The number of patients that have restoration of flow in the treated vein as measured by X-ray.
Time frame
Immediately after the study procedureSecondary outcomes
1
Vein Patency
The number of patients that have vein patency as measured by duplex ultrasound or other imaging.
Time frame
Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.2
Vein Disability Score
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.
Time frame
Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure3
Villalta Score
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.
Time frame
Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure4
Quality of Life
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.
Time frame
Baseline, 1 Month, 6 Months, 12 Months, 24 Months after the study procedure.Other outcomes
1
Additional Safety Events
The number of patients that have serious adverse events (SAEs) will be evaluated.
Time frame
Up to 24 months after the study procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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