Clinical Research Directory

Vflower Stent System for Iliofemoral Vein Stenosis and Occlusion: A Multicenter Real-World Study

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Summary

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.

Official title: Vflower Stent System for the Treatment of Iliofemoral Vein Stenosis and Occlusion: A Multicenter, Real-World Study

Key Details

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Interventions