NCT03810677已完成不适用
Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?
be Medical2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Anatomic success
研究概览
简要总结
This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient is at least 18 years old.
- •Patient must sign and date the informed consent form prior to treatment.
- •Presence of unilateral or bilateral primary symptomatic varicose veins (CEAP grade ≥ C2).
- •Patient has an insufficient Great Saphenous Vein (GSV), with or without laser ablation of anterior accessory saphenous vein (AASV), posterior accessory saphenous vein (PASV), and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence), suitable for endovenous laser ablation (EVLA).
- •Maximum diameter of the to be treated veins is ≤ 14mm.
排除标准
- •Current deep vein thrombosis.
- •Acute superficial thrombosis.
- •Mean diameter of the to be treated veins > 14mm.
- •Tortuous or very superficial veins considered unsuitable for laser treatment.
- •Recurrent varicose veins.
- •Coagulopathy or bleeding disorders.
- •Contraindications to the use of general or regional anesthesia.
结局指标
主要结局
Anatomic success
时间窗: at 12 months follow-up
defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography
次要结局
- Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)(at 12 months follow-up)
- Post-operative adverse events(at 12 months follow-up)
- Procedural characteristics(at index-procedure)
- Pain scoring using the Visual Analog Scale (VAS)(at 1 week follow-up)
- Re-interventions(at 12 months follow-up)
研究者
研究点 (2)
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