NCT07102160招募中不适用
A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)
Argon Medical Devices4 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2026年2月4日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 185
- 试验地点
- 4
- 主要终点
- Technical Success
研究概览
简要总结
The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the Cleaner Vac® Thrombectomy System for the treatment of thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). This prospective, multi-center, open-label study will assess clinical outcomes, device performance, and procedural success in a single DVT study cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Participants must meet all the following criteria to be eligible for the study:
- •At least 18 years of age at the time of consent.
- •Undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body.
- •Written informed consent obtained through the IRB-approved ICF.
- •For the DVT cohort, participants must meet all criteria above and below to be eligible for the study:
- •Present with unilateral or bilateral lower extremity DVT involving at least one of the following veins:
- •Femoral-popliteal vein
- •Common femoral vein
- •Inferior Vena Cava (IVC)
- •DVT diagnosis confirmed by imaging within 14 days of the index procedure.
- •Symptomatic DVT with onset within 6 weeks of enrollment.
排除标准
- •Subjects will be excluded from the study if any of the following criteria are met:
- •Contraindication to systemic or therapeutic doses of anticoagulants.
- •Contraindication to iodinated contrast that cannot be adequately premedicated.
- •Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
- •Patients that are pregnant.
- •Known coagulation disorders both acquired (Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period.
- •Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
- •Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.
- •Known history of a Patent Foramen Ovale (PFO).
- •Hemoglobin < 8.0 g/dL, INR > 2.0 before warfarin was started, or platelets < 50,000/µl which cannot be corrected prior to enrollment.
- •Severe renal impairment (estimated GFR < 30 ml/min) in patients who are not yet on dialysis. Patients with GFR <30 ml/min who are already on dialysis can be enrolled.
- •Patients with intermediate-high risk or high-risk pulmonary embolism (PE) defined as follows:
- •High-risk PE: Presence of hemodynamic instability, including cardiac arrest, obstructive shock (systolic blood pressure <90 mmHg or need for vasopressors with signs of end-organ hypoperfusion), or persistent hypotension (systolic BP <90 mmHg or a drop ≥40 mmHg for >15 minutes not due to other causes)
- •Intermediate-high-risk PE: Hemodynamically stable patients with both right ventricular (RV) dysfunction (on echocardiography or CT) and elevated cardiac biomarkers (e.g., troponin).
- •Complete infrarenal IVC occlusion.
- •Chronic non-ambulatory status.
- •Current enrollment in another investigational device or drug study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
研究组 & 干预措施
DVT Subgroup
This is a defined cohort focused on patients with lower extremity proximal deep vein thrombosis (DVT) who will undergo treatment with Cleaner Vac® Thrombectomy System. Participants will complete required follow-up at discharge and at 1, 6, 12, and 24 months.
干预措施: Aspiration thrombectomy system (Device)
结局指标
主要结局
Technical Success
时间窗: At the time of the index procedure
≥75% thrombus removal in the target venous segment, assessed by change in Marder Score
Composite rate of Major Adverse Events (MAEs) within 30 days post-procedure
时间窗: 30 days post-index procedure
次要结局
- Freedom from Device- or Procedure-Related Serious Adverse Events (SAEs)(30 days post-procedure)
- Post-Thrombotic Syndrome Severity(Up to 24 months)
- Venous patency(From 30 days post-treatment to the end of the study period)
- Need for Target Vessel Reintervention(From date of index procedure up to 24 months)
- Numeric Pain Rating Scale(Up to 24 months)
研究者
研究点 (4)
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