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
Qualifiers
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 design
Treatments tested in this trial
- Mechanical Thrombectomy - Standard of Care procedure for venous thrombosis
Treatment groups
218 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov