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.
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-C6.
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.
This is a single-cohort study population of approximately 310 adult patients (aged ≥18 years) with symptomatic iliofemoral vein stenosis (≥75%) or complete occlusion, with CEAP clinical classification C3-C6. The population includes patients presenting with chronic venous disease manifestations including lower limb edema, pain, heaviness, skin changes (pigmentation, eczema, lipodermatosclerosis), or active/healed venous ulcers. All enrolled patients are able to tolerate antiplatelet/anticoagulant therapy and willing to comply with all study procedures and scheduled follow-up visits at 1, 6, 12, and 24 months post-procedure.
Cohort
Prospective
Vflower venous stent system (self-expanding nitinol stent for iliofemoral venous lesions)
DevicePercutaneous balloon angioplasty of the iliofemoral vein prior to stent placement
12-Month Target Lesion Patency Rate
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.
Device Success Rate
Successful delivery and deployment of the stent and uneventful removal of the delivery system, with no conversion to open surgery and no death within 24 hours post-procedure.
Procedural Success Rate
Technical success and no major adverse events before discharge.
Technical Success Rate
Post-procedural angiographic residual stenosis ≤50% at the target lesion. Ancillary interventions performed during the procedure are not counted as technical failure.
Change in CEAP Clinical Classification
Improvement of ≥1 grade in CEAP clinical classification compared to baseline, assessed at 6 months, 12 months, and 2 years post-procedure.
Change in Venous Clinical Severity Score (VCSS)
Improvement of ≥2 points in VCSS compared to baseline, assessed at 6 months, 12 months, and 2 years post-procedure.
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