[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655275":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":47,"studyPopulation":48,"armGroups":49,"interventions":55,"overallOfficials":44,"centralContacts":61,"locations":44,"responsibleParty":67,"collaborators":44,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":44,"enrollmentInfo":81,"targetDuration":84,"studyType":85,"phases":44,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":103,"whyStopped":44,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":44},{"fullName":5,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"12-Month Target Lesion Patency Rate","Target lesion patency at 12 months, defined as no thrombosis or occlusion, no secondary surgical\u002Finterventional intervention (excluding non-target lesions), and in-stent stenosis ≤50%, assessed by DSA, duplex ultrasonography, or CTV.","12 months",[14],{"measure":15,"description":16,"timeFrame":17},"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.","Perioperative\u002FPeriprocedural",[19,22,25,29,32,36,40],{"measure":20,"description":21,"timeFrame":17},"Procedural Success Rate","Technical success and no major adverse events before discharge.",{"measure":23,"description":24,"timeFrame":17},"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.",{"measure":26,"description":27,"timeFrame":28},"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.","Baseline, 6 months, 12 months, and 24 months",{"measure":30,"description":31,"timeFrame":28},"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.",{"measure":33,"description":34,"timeFrame":35},"Target Lesion Revascularization Rate","Rate of repeat endovascular treatment or revascularization for the target lesion when clinically indicated or when stenosis ≥50% at the most narrowed segment of the target lesion.","6 months, 12 months, and 24 months",{"measure":37,"description":38,"timeFrame":39},"Incidence of Major Adverse Events (MAE)","Includes device\u002Fsurgery-related death, arteriovenous injury of the target vessel or target lesion requiring surgical\u002Finterventional treatment, symptomatic pulmonary embolism, device\u002Fsurgery-related major bleeding requiring transfusion\u002Fsurgical\u002Finterventional treatment, in-stent thrombosis, and device\u002Fsurgery-related acute deep vein thrombosis.","up to 30 days",{"measure":41,"description":42,"timeFrame":35},"Adverse Events","Adverse medical events occurring during follow-up, regardless of relationship to the investigational device.",{"allocation":44,"interventionModel":44,"interventionModelDescription":44,"primaryPurpose":44,"observationalModel":45,"timePerspective":46,"maskingInfo":44},null,"COHORT","PROSPECTIVE","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.\n\nStudy 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.\n\nStudy 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.\n\nProcedure: 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.\n\nFollow-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).\n\nPrimary Outcome: The primary outcome is the technical and clinical success rate, defined as the patency rate of the treated vein segment at 12 months post-procedure, as assessed by venous duplex ultrasonography.\n\nSecondary Outcomes: Secondary outcomes include: (1) the change in VCSS from baseline to each follow-up visit; (2) the rate of freedom from target lesion revascularization at 12 and 24 months; (3) the incidence of device-related and procedure-related adverse events, including stent thrombosis, restenosis, stent migration, and bleeding complications; (4) health-related quality of life assessed by validated instruments; and (5) the rate of vein patency at 6, 12, and 24 months.\n\nData Collection: Study data will be collected using electronic case report forms (eCRFs). Data sources include medical records, imaging reports, laboratory results, and patient-reported outcomes. A centralized data management system will be used for data storage, with regular monitoring for data quality and completeness.\n\nStatistical Analysis: Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be presented as frequencies and percentages. Vein patency rates will be estimated using the Kaplan-Meier method, with 95% confidence intervals. Adverse events will be coded using standardized terminology and summarized by severity and relationship to the device\u002Fprocedure.\n\nEthical Considerations: The study protocol has been approved by the institutional review boards of all participating centers. Written informed consent will be obtained from all participants prior to enrollment. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.","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\u002Fhealed venous ulcers. All enrolled patients are able to tolerate antiplatelet\u002Fanticoagulant therapy and willing to comply with all study procedures and scheduled follow-up visits at 1, 6, 12, and 24 months post-procedure.",[50],{"label":51,"type":44,"description":52,"interventionNames":53},"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.",[54],"Device: Vflower venous stent system (self-expanding nitinol stent for iliofemoral venous lesions)",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":44},"DEVICE","Vflower venous stent system (self-expanding nitinol stent for iliofemoral venous lesions)","Percutaneous balloon angioplasty of the iliofemoral vein prior to stent placement",[51],[62],{"name":63,"role":64,"phone":65,"phoneExt":44,"email":66},"Zhi Wei Zhang","CONTACT","15950079779","zhangzw517@163.com",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Zhiwei Zhang","Associate Chief Physician","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":82,"type":83},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.",[88,89],"Iliofemoral Vein Stenosis","Iliofemoral Vein Occlusion",[88,89,91,92,93,94,95,96,97,98,99,100,101,102],"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":106,"type":107},"2026-09-09","ACTUAL",{"date":109,"type":83},"2026-10",{"date":111,"type":83},"2028-01",{"name":5,"class":6}]