[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"iliofemoral-vein-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:iliofemoral-vein-stenosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100655275","vflower-stent-system-for-iliofemoral-vein-stenosis-and-occlusion-a-multicenter-real-world-study-100655275",false,"NCT07809204","Vflower Stent System for Iliofemoral Vein Stenosis and Occlusion: A Multicenter Real-World Study","Vflower Stent System for the Treatment of Iliofemoral Vein Stenosis and Occlusion: A Multicenter, Real-World Study","V-STAR","Inclusion Criteria:\n\n* Inclusion Criteria\n\n  1. Age ≥18 years.\n  2. Symptomatic iliofemoral vein stenosis (≥75%) or complete occlusion, confirmed by imaging (duplex ultrasonography, CTV, MRV, or DSA).\n  3. CEAP clinical classification C3-C6.\n  4. Willing and able to provide written informed consent and comply with all study requirements, including scheduled follow-up visits.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation.\n2. Known hypersensitivity or contraindication to nitinol, contrast media, or antiplatelet\u002Fanticoagulant medications that cannot be managed.\n3. Active systemic infection or untreated sepsis.\n4. Life expectancy \\\u003C12 months due to non-venous comorbidities.\n5. Inability to tolerate antiplatelet or anticoagulant therapy.\n6. Concurrent enrollment in another investigational device or drug study.\n7. Iliofemoral venous lesions not amenable to endovascular treatment as determined by the investigator.","ALL","18 Years",{"count":20,"type":21},310,"ESTIMATED","24 Months","OBSERVATIONAL","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.\n\nPatients 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.\n\nThis 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.\n\nThe 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.",[26,27],"Iliofemoral Vein Stenosis","Iliofemoral Vein Occlusion",[26,27,29,30,31,32,33,34,35,36,37,38,39,40],"Deep Vein Thrombosis","Post-thrombotic Syndrome","Venous Stent","Vflower Stent","Balloon Angioplasty","Endovascular Procedure","Observational Study","Real-World Study","Multicenter Study","Vein Patency","Venous Clinical Severity Score","VCSS","NOT_YET_RECRUITING","2026-09-03",{"date":44,"type":45},"2026-09-09","ACTUAL",{"date":47,"type":21},"2026-10",{"date":49,"type":21},"2028-01",{"name":51,"class":52},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER"]