NCT03455699已完成不适用
Follow-up of Patients Treated in VeClose Study (Five Years)
Medtronic Endovascular9 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2016年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 9
- 主要终点
- Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).
研究概览
简要总结
The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).
详细描述
The VeClose Five Year Follow-up Extension Study will continue to assess the safety and efficacy of the VenaSeal Closure System for the long term effect on closure of the great saphenous vein by conducting a follow-up visit at five years post index procedure/enrollment in the VeClose study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the VeClose study.
- •Able and willing to complete the required 5 year study visit including Duplex ultrasound exam.
- •Able and willing to provide written informed consent prior to study specific data collection.
排除标准
- •Withdrew consent from the VeClose study.
结局指标
主要结局
Complete Closure of the Target Vein at 5 years after index treatment in the VeClose study (NCT01807585).
时间窗: 5 years
Complete closure is defined as Doppler ultrasound examination showing closure along entire treated target vein segment with no discrete segments of patency exceeding 5cm.
次要结局
- Aberdeen Varicose Vein Questionnaire (AVVQ)(5 years)
- CEAP classification ("clinical, etiology, assessment and pathophysiology")(5 years)
- Satisfaction with Treatment(5 years)
- Adverse events (AE) related to the target GSV(5 years)
- Adjunctive procedures performed on the study limb(5 years)
- Venous Clinical Severity Score (VCSS)(5 years)
- Quality of Life survey (EQ-5D)(5 years)
研究者
研究点 (9)
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