ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 326
- 主要终点
- Percentage of Limbs Without Vein Occlusion
研究概览
简要总结
The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters.
详细描述
The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years of age at the time of enrollment
- •Symptomatic lower limb venous disease involving the GSV
排除标准
- •Thrombosis in the vein segment to be treated
- •Known or suspected pregnancy or actively breast feeding at time of treatment
研究组 & 干预措施
Seg. RF Ablation with CLF catheter
Single Arm with CLF Catheter
干预措施: RF ablation (ClosureFAST) (Device)
结局指标
主要结局
Percentage of Limbs Without Vein Occlusion
时间窗: 5 years
Defined as the absence of flow in the treated vein as documented on the post-procedure and follow-up DU scan. Flow which originates in the SFJ and which measures \< 3 cm in length, does not constitute a failure.
Percentage of Limbs Without Reflux in the Treated Vein Segment
时间窗: 5 years
No reflux in the vein segment treated. Reflux was defined as reversal flow \>0.5s with subject standing or in reverse Trendelenburg position of at least 15° after distal augmentation.
次要结局
- Presence of Complications From GSV Intervention(5 years)
- CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) Classification(Baseline)
- CEAP Classification(5 years)
- Change in Venous Clinical Severity Score (VCSS) From Baseline to 5Y Follow-up(Baseline thru 5 years)
- Visual Analog Pain Scale (VAS)(5 years)
- Presence of Complications From Greater Saphenous Vein (GSV) Intervention(1 Week)