The Safety & Efficacy of Endovenous Laser Ablation of Superficial Vein in Patients with Combined Superficial and Segmental Deep Venous Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- safety & efficacy of endovenous laser ablation of superficial veins in patients with combined superficial and segmental deep venous disease
研究概览
简要总结
Great saphenous vein (GSV) reflux is important in the development of signs and symptoms of chronic venous insufficiency. The combination of varicose veins and deep vein thrombosis (DVT) / deep venous insufficiency is a common clinical scenario. In the presence of combined superficial and deep vein reflux, it is always possible to treat superficial reflux.
This is a single-center, single-arm, prospective interventional study to evaluate the safety & efficacy of Endo-venous laser ablation of the superficial saphenous veins in patients combined with superficial & deep venous disease. The primary outcome measures will be the improvement in venous clinical severity score at 1 & 3 months & secondary outcome measures will be to evaluate the technical success rate & the incidence of recurrent DVT post-procedure, other complications, and recurrence of varicose veins at 1 & 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •patients with varicose veins with both superficial & deep venous reflux patient with >70% recanalized chronic deep venous thrombosis with superficial reflux patients with post-thrombotic varicose veins with superficial reflux will be included in the study.
排除标准
- •1.Patient with acute DVT.
- •2.Pregnancy.
- •3.Patients on chronic hemodialysis.
- •4.Non-consenting patients.
结局指标
主要结局
safety & efficacy of endovenous laser ablation of superficial veins in patients with combined superficial and segmental deep venous disease
时间窗: POST OPERATIVE DAY 1, 1 MONTH & 3 MONTH
次要结局
- rate of technical success, the incidence of recurrent DVT post procedure, other complications, and recurrence of varicose veins.(POST OPERATIVE DAY 1, 1 MONTH & 3 MONTHS.)