NCT02585726已完成不适用
Lake Washington Vascular VenaSeal™ Post-Market Evaluation: WAVES
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
研究概览
简要总结
The VenaSeal Closure system offers an outpatient treatment option for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. VenaSeal is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Reflux in at least one target vein;
- •One or more of the following symptoms related to a TV: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling;
- •CEAP classification of C2 (if symptomatic) through C5;
排除标准
- •Current, regular use of systemic anticoagulation;
- •Previous or suspected deep vein thrombosis or pulmonary embolus, or active acute superficial thrombophlebitis, or thrombophlebitis migrans;
- •Previous treatment such as laser or radiofrequency ablation of venous disease in targeted vein segment;
- •Known hypercoagulable disorder;
- •Pregnant or breast feeding at enrollment;
- •Known sensitivity to cyanoacrylate adhesives;
- •Venous treatment in the contralateral limb within the last 30 days, or who require contralateral treatment within three months;
- •Planned to undergo additional ipsilateral treatments on the same leg within 3 months following treatment.
结局指标
主要结局
Complete closure (CC) of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
时间窗: 1 month
CC of the PTVS as assessed by duplex ultrasound 1 month after the index procedure.
次要结局
- Return to normal activities and return to work; day of procedure is day 0(1 week, 1 month)
- Safety and adverse event for below the knee greater saphenous vein treatment(1 week, 1 month, 3 months)
- Need for adjunctive treatment(3 months)
- CC of the PTVS, as assessed by duplex ultrasound(1 week and 3 months after treatment)
- Quality of life as measured by the Aberdeen Varicose Vein Questionnaire (AVVQ)(1 and 3 months after treatment)
- Quality of life as measured by the EQ-5D(1 and 3 months after treatment)
- CC of TVS, expressed on a per-segment basis(1 month and 3 months)
- Quality of life as measured by the venous clinical severity scores (rVCSS)(1 and 3 months after treatment)
- CC of Treated Vein Segments (TVS), expressed on a per-segment basis, as assessed by duplex ultrasound(1 month and 3 months after the index procedure)
- Safety and adverse events for large diameter TVS defined as veins larger than 8 mm in diameter(1 week, 1 month, 3 months)
- Patient satisfaction(1 week, 1 month, 3 months)
研究者
研究点 (2)
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