Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 547
- 试验地点
- 1
- 主要终点
- Adjunctive phlebectomy
研究概览
简要总结
This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation).
详细描述
This single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. The overall cost of treatment for both groups will be compared.
Some of the secondary aims of this study include:
- To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment.
- To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups.
- To assess the need for adjunctive therapies.
- To record and compare retrospectively the adverse events between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •Limb with saphenous vein incompetence, treated with one of the following:
- •VenaSeal ™ Endovenous Laser Ablation Radiofrequency Ablation
- •CEAP Clinical Class between 2-5
- •Limb treated from October 1st, 2015-present
- •At least 2 months of follow-up post index procedure
- •Treatment of either the great saphenous vein (GSV), the small saphenous vein (SSV), or both. Treatment of accessory saphenous veins (ASV) is allowed as long as either the GSV, SSV, or both the GSV and SSV were treated as well in that limb at the index procedure.
排除标准
- •Limb treatment of the accessory saphenous vein (ASV) without concomitant great saphenous vein (GSV) and/or small saphenous vein (SSV) treatment
- •Limb treatment for reasons other than symptomatic varicose veins
- •Limbs without follow-up information at least 2 months following the index procedure
- •Subjects who participated in another clinical trial as part of their saphenous vein treatment
- •Investigator decision (concurrent condition that would make inclusion inappropriate, protected subject population) -
结局指标
主要结局
Adjunctive phlebectomy
时间窗: Through 6 months of index procedure
Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure
Cost of Treatment
时间窗: Through six months of index procedure
A cost analysis will be performed calculating the total cost of treatment between groups
次要结局
- Severity of Disease(At treatment through six months of index procedure)
- Utilization of adjunctive treatments(Through six months of index procedure)
- Adverse events reported during clinic visits(Though six months of index procedure)