Vflower Stent System for the Treatment of Iliofemoral Vein Stenosis and Occlusion: A Multicenter, Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 310
- 主要终点
- 12-Month Target Lesion Patency Rate
研究概览
简要总结
This multi-center, real-world observational study is being conducted at five hospitals in China to evaluate the effectiveness of the Vflower venous stent system in patients with iliofemoral vein stenosis or occlusion. Iliofemoral vein stenosis or occlusion occurs when the large veins in the pelvis or thigh become narrowed or blocked, which can cause leg swelling, pain, varicose veins, skin changes, and in severe cases, non-healing ulcers. Approximately 310 adult patients (18 years and older) will participate in this study.
Patients who require treatment for this condition will undergo a minimally invasive procedure called balloon angioplasty and stent placement. During the procedure, a physician inserts a catheter through a small puncture in the groin or leg, inflates a small balloon to open the narrowed vein, and then places a Vflower venous stent-a specially designed metal mesh tube-to keep the vein open. The Vflower stent has been approved by China's National Medical Products Administration for use in this condition.
This is an observational study, meaning your treating physician will make all treatment decisions based on your medical needs. The research team will collect data from your routine medical visits, examinations, and tests. You will be asked to return for follow-up visits at 1 month, 6 months, 12 months, and 24 months after the procedure to assess whether the vein remains open, to evaluate your symptoms, and to monitor for any complications.
The primary outcome of the study is the rate at which the treated vein remains open (patent) at 12 months after the procedure. Additional outcomes include patient-reported symptom improvement, the need for repeat procedures, and the occurrence of any complications. Participation in this study does not require any extra tests or procedures beyond those you would normally receive as part of your standard medical care. You may choose not to participate or to withdraw at any time without affecting your regular medical treatment.
详细描述
This is a prospective, multicenter, real-world observational study conducted at five hospitals in China. The study aims to evaluate the effectiveness and safety of the Vflower venous stent system in adult patients with symptomatic iliofemoral vein stenosis or occlusion.
Study Design: This is an observational (non-randomized) study. Treatment decisions, including the choice of stent type and procedural technique, will be made by the treating physicians based on each patient's clinical condition. The research team will collect prospective data from routine clinical visits, imaging examinations, and laboratory tests performed as part of standard patient care.
Study Population: Approximately 310 adult patients (aged 18 years or older) with symptomatic iliofemoral vein stenosis or occlusion will be enrolled. Inclusion criteria require symptomatic disease (e.g., leg swelling, pain, varicose veins, or skin changes) and angiographic evidence of iliofemoral vein stenosis of 75% or greater, or complete occlusion. Patients with contraindications to anticoagulation, active infection, or other conditions that would preclude standard endovascular treatment will be excluded.
Procedure: Eligible patients will undergo standard endovascular intervention, which includes balloon angioplasty followed by placement of the Vflower venous stent. The Vflower stent is a self-expanding nitinol stent specifically designed for venous application, with a unique flower-shaped geometry that provides radial force while accommodating venous pulsatility and movement. The stent has been approved by the China National Medical Products Administration for use in iliofemoral venous lesions.
Follow-up and Assessments: Patients will be followed at 1 month, 6 months, 12 months, and 24 months after the procedure. At each follow-up visit, patients will undergo clinical evaluation, venous duplex ultrasonography to assess vein patency, and completion of validated patient-reported outcome questionnaires, including the Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification and the Venous Clinical Severity Score (VCSS).
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
- •Inclusion Criteria
- •Age ≥18 years.
- •Symptomatic iliofemoral vein stenosis (≥75%) or complete occlusion, confirmed by imaging (duplex ultrasonography, CTV, MRV, or DSA).
- •CEAP clinical classification C3-C
- •Willing and able to provide written informed consent and comply with all study requirements, including scheduled follow-up visits.
排除标准
- •Pregnancy or lactation.
- •Known hypersensitivity or contraindication to nitinol, contrast media, or antiplatelet/anticoagulant medications that cannot be managed.
- •Active systemic infection or untreated sepsis.
- •Life expectancy <12 months due to non-venous comorbidities.
- •Inability to tolerate antiplatelet or anticoagulant therapy.
- •Concurrent enrollment in another investigational device or drug study.
- •Iliofemoral venous lesions not amenable to endovascular treatment as determined by the investigator.
研究组 & 干预措施
Vflower USED GROUP
One cohort of approximately 310 adult patients (aged ≥18 years) with symptomatic iliofemoral vein stenosis (≥75%) or complete occlusion who undergo balloon angioplasty and Vflower venous stent placement.
干预措施: Vflower venous stent system (self-expanding nitinol stent for iliofemoral venous lesions) (Device)
结局指标
主要结局
12-Month Target Lesion Patency Rate
时间窗: 12 months
Target lesion patency at 12 months, defined as no thrombosis or occlusion, no secondary surgical/interventional intervention (excluding non-target lesions), and in-stent stenosis ≤50%, assessed by DSA, duplex ultrasonography, or CTV.
次要结局
- Device Success Rate(Perioperative/Periprocedural)
研究者
Zhiwei Zhang
Associate Chief Physician
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine