跳至主要内容
临床试验/NCT02248740
NCT02248740终止4 期

Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein: A Prospective Randomized Trial

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2008年9月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
入组人数
36
试验地点
2
主要终点
Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.

研究概览

简要总结

The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency related to the Small Saphenous Vein (SSV) to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.

详细描述

Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. The second most common cause is a refluxing or incompetent Small Saphenous Vein (SSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the SSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the SSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with symptomatic chronic venous insufficiency.
  • Patients in whom endovenous thermal ablation is clinically indicated.
  • Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
  • Have symptoms secondary to Small Saphenous Vein insufficiency defined as reverse flow in the saphenous vein >0.5 seconds after calf compression or while standing.

排除标准

  • Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures).
  • Have a history of Deep Venous Thrombosis (DVT).
  • Have a history of hypercoaguability disorder.
  • Are pregnant or breastfeeding.
  • Are nonambulatory.

研究组 & 干预措施

Radiofrequency Ablation

Active Comparator

Device: ClosureFast radiofrequency catheter (VNUS Medical Technologies Inc, San Jose, CA).

Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.

干预措施: Ablation of the incompetent small saphenous vein (Procedure)

Laser Ablation

Active Comparator

Device: EVLT 980nm diode laser system (Angiodynamics, Queensbury, NY).

Patients will have the intervention, ablation of the incompetent small saphenous vein, using this device.

干预措施: Ablation of the incompetent small saphenous vein (Procedure)

结局指标

主要结局

Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.

时间窗: At 10 years after treatment.

次要结局

  • Incidence Rate of Acute Complications(1 and 6 weeks post intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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