Evaluation of the Zilver® Vena™ Venous Stent in the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 59
- 主要终点
- The Rate of Participants With Primary Quantitative Patency at 12 Months
研究概览
简要总结
The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •symptomatic venous outflow obstruction in one iliofemoral venous segment (i.e., one limb) per patient, demonstrated by:
- •CEAP "C" ≥ 3, or
- •VCSS pain score ≥ 2
排除标准
- •< 18 years of age;
- •pregnant or planning to become pregnant in the next 12 months;
- •planned surgical or interventional procedures of the target limb (except thrombolysis and/or thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or any time after the study procedure;
- •planned surgical or interventional procedures for other medical conditions (i.e., not associated with the target limb) within 30 days prior to or after the study procedure;
- •lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter;
- •lesion with malignant obstruction;
- •previous stenting of the target vessel;
- •iliofemoral venous segment unsuitable for treatment with available sizes of study devices.
结局指标
主要结局
The Rate of Participants With Primary Quantitative Patency at 12 Months
时间窗: 12 months
Primary quantitative patency was defined as a treated venous segment that retained (uninterrupted; intervention-free) an MLD (Minimum Lumen Diameter ) \> 50% of the immediate post-procedure stented MLD as demonstrated by venography as determined by the core laboratory.
Number of Participants With 30-day Freedom From Major Adverse Events
时间窗: 30 days
Major adverse events were defined as procedural bleeding requiring transfusion, procedure- or device-related death, clinically driven target lesion reintervention, clinical migration, new symptomatic PE, or procedure-related perforation requiring open surgical repair or flow-limiting dissection of the target vessel.
次要结局
- Change From Baseline in the Venous Clinical Severity Score (VCSS) at 1 Month(Baseline and 1 month)
- Change From Baseline in the Venous Clinical Severity Score (VCSS) at 12 Months(Baseline and 12 months)