Prospective, Multicenter, Registry of the FLOWRUNNER Aspiration System for Safety and Effectiveness in the Removal of Symptomatic Venous Thrombosis (FAST)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 218
- 主要终点
- Procedure Success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •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).
- •Willing and able to participate and comply with all protocol-required follow-up visits and assessments.
排除标准
- •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
- •Estimated life expectancy of less than 12 months, based on the investigator's clinical judgement, available medical history, and prognostic indicators.
- •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
- •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
- •Renal dysfunction (eGFR < 30 mL/min/1.73m2, not yet on dialysis).
- •Cerebral or myocardial infarction in the last 3 months.
- •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
结局指标
主要结局
Procedure Success
时间窗: 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
时间窗: 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
时间窗: Immediately after the study procedure
The number of patients that have restoration of flow in the treated vein as measured by X-ray.
次要结局
- 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.)