NCT01079598终止不适用
A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet
Medtronic Endovascular6 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 6
- 主要终点
- Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.
研究概览
简要总结
The purpose of this study is to demonstrate that patients will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator veins (IPVs).
详细描述
The purpose of this study is to demonstrate that patients who have competent great saphenous vein (GSV) and short saphenous vein (SSV) or have undergone prior successful endovenous treatment of an incompetent GSV and/or SSV but continue to demonstrate clinical symptoms of peripheral venous insufficiency resulting from incompetent perforator veins (IPVs) will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of IPVs veins.
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
- •Male and female, ages 18 to 80 years, from all racial and ethnic origin
- •Have the ability to understand the requirements of the study, provide written informed consent to participate, and agree to abide by the study requirements
- •Available for all the follow-up visits and in a physical condition allowing ambulation after the procedure
- •Incompetent GSV and/or SSV in the target limb has been treated at least 3 months before study enrollment or competent GSV and SSV at time of treatment
- •CEAP 4 - 6 classification
- •DUS reflux of ≥0.35 sec or more of the target IPV and/or an intra-fascia diameter of ≥0.3 mm
排除标准
- •Acute (at Screening) superficial venous thrombosis of either limb
- •Acute (within the prior 3 months) deep venous thrombosis or phlebitis in either limb
- •Complete or near complete deep venous obstruction documented by ultrasound
- •Previously participated in any study involving ClosureRFS
- •Actively participated in any other investigational study within 30 days of enrollment into this study
- •Pregnant at the time of treatment. Status verified by pregnancy test via blood or urine for women ≤ 55 years old.
- •Having a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all required study follow-up
- •Have any condition that, in the opinion of the Investigator, would jeopardize the safety of the patient or affect the validity of the trial results
- •Have a history of excessive alcohol consumption or any use of illegal drugs rendering the patient unreliable, or at risk during this trial
- •Have undergone major surgery which may result in abnormalities of the target body area, reasonably suspected to compromise the study outcomes
- •Have undergone an invasive procedure of the target body area (e.g., needle biopsy or surgical procedure) within 30 days of enrollment into this study
- •Known incompatibility, such as an allergic reaction to anesthetics to be used in the incompetent perforator vein treatment
- •Patients requiring hyperbaric therapy involving the treated limb during the 6 month post treatment follow-up period
- •Great toe pressure measurement of ≤ 70 mmHg
- •CEAP 6 classified patients receiving high dose steroid medication or the following medications that interfere with normal mechanisms of wound healing, e.g. glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), anti-neoplastic and immunosuppressive drugs, and others like, colchicine and penicillamine.
- •Expressing a body mass index (BMI) of ≥ 35.
结局指标
主要结局
Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.
时间窗: 6 months
QOL and clinical assessments measured by periodic CIVIQ2 and VCSS assessments were planned to be compared at each follow-up visit to pretreatment baseline. However, with the very low enrollment and limited data available, analysis and study results are inconclusive.
次要结局
- Cessation of Flow Through the Perforator Vein(6 months)
- CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)(6 months)
- Cessation of Flow Reflux Through the Perforator Vein(6 months)
研究者
研究点 (6)
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