V.A.S.C. (Vacuum Assisted Sclerotherapy Performed by Catheter)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Confirm the safety and performances of VelexTM device when used in accordance with the Instructions for Use
研究概览
简要总结
VelexTM Venous Catheter is a venous catheter for temporary use to treat a vein isolated segment, designed for the treatment of varicose veins of lower limbs by means of chemical ablation or empty-vein sclerotherapy.
V.A.S.C. is a multicentric, prospective, open label, non-randomized PMCF study of VelexTM venous catheter used according to the indication of use within the scope of the CE mark.
VelexTM venous catheter is intended for patients with varicose veins of lower limbs. The total minimum number of patients is 24 and the maximum 36 for the two centers participating. Each center shall enroll at least 8 patients andno more than 28.
详细描述
V.A.S.C. is a multicentric prospective, open label, non-randomized PMCF study of VelexTM venous catheter for patients with varicose veins of lower limb.
The study is designed as a post-market clinical follow-up, aimed at collecting clinical data of VelexTM venous catheter used according to the indication of use within the scope of the CE mark.
The study will enrol a maximum number of 36 patients at the participating sites. All the subjects will be evaluated at immediate post-procedure, 7 days, 1, 3 and 6 months after the procedure.
The eligibility criteria are compliant with the indication of use within the scope of the CE mark.
Several preclinical tests were carried out for assessing the safety of VelexTM venous catheter: in vitro tests, biocompatibility and preclinical-vivo test.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years old
- •Weight >45 kg
- •Asymptomatic or presence of at least one of the following symptoms: pain, heaviness, tiredness, itching, night cramps, restlessness, general discomfort, swelling.
- •GSV standing diameter between 4 and 12 mm along the whole veins (measured by Duplex ultrasound)
- •Willingness to undergo follow-up visits
- •Ability to understand scope, content and risks of the study, and provide informed consent to participation
排除标准
- •Contraindications for endovascular procedures (fever, infectious processes, tumor diseases, hemorragic diathesis)
- •Any disease or condition contraindicating sclerotherapy treatment
- •Peripheral symptomatic arterial pathology (ankle brachial index ABI <0.80)
- •History or suspect of Deep Venous Thrombosis (DVT) or Superficial Venous Thrombosis of Great Saphenous Vein (SVT of GSV)
- •GSV standing diameter > 12 mm for vein segments longer than 3 cm or diameter < 4 mm for segments longer than 5 cm
- •Caprini score >10
- •Pregnancy and breastfeeding
- •Previous treatments of venous pathologies in the leg (excluding telangiectasis and reticular venulas)
- •Allergy to sclerosant agent
- •Participation in another clinical trial
结局指标
主要结局
Confirm the safety and performances of VelexTM device when used in accordance with the Instructions for Use
时间窗: 3 months
After 3 months, patients will be asked to fill a questionnaire of quality of life.
Pain level
时间窗: 7 days from the procedure
Evaluated and recorded the pain post the procedure with the pain score scale: Visual analogue scale (VAS) 0= NO PAIN 1-3=MILD PAIN 4-6= MODERATE/SEVERE PAIN 7-9= VERY SEVERE PAIN 10=WORST PAIN POSSIBLE
次要结局
未报告次要终点