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临床试验/NCT02345018
NCT02345018已完成不适用

Registry of the Treatment of Primary Insufficiency of the Great Saphenous Vein With a Diameter >/= 12 mm, Antero-lateral Branches, or Great Saphenous Vein Insufficiency Below the Knee With Mechano-chemical Endovenous Ablation (MOCA)

Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Clinical success

研究概览

简要总结

The goal of this registry study is to provide insight in the safety and efficacy of treatment with MOCA for primary insufficiency of the GSV with a diameter >/=12mm, insufficient antero-lateral branches and insufficiency of the GSV below the knee.

详细描述

Varicose veins are a common problem in the World. From epidemiological studies we know that a quarter of the adult population suffers from some sort of varicose veins. Women suffer two to three times more often from varicose veins than men. The occurrence of varicose veins increase with increasing age and is one of the top ten complaints for which patients visit their general practitioner. De main risk factors for developing varicose veins are enduring standing or sitting, pregnancy, female gender and age. Symptoms are divers and vary from cosmetic complaints to difficult to treat venous ulcers.

Last few years endovenous techniques have been developed for the primary treatment of insufficient varicose veins. Radiofrequent ablation (RFA)is, besides endovenous laser ablation (EVLA), an accepted technique and is frequently applied in clinical practice. This technique, that uses heat, has the important advantage that the treatment can be performed using a slight local anaesthesia. Besides that, RFA causes less hematoma, pain, a superior cosmetic and patient are able to restart daily activities sooner than compared to the classical surgical treatment. Because RFA using heat technology, damage can occur in the surrounding tissues. That is the reason for using tumescent anaesthesia, for which multiple injections are needed. A column of liquid is placed surrounding the vein. Many patients experience this column as inconvenient and despite this form of anaesthesia part of the treated patient population experiences pain after the treatment that can last up to weeks.

A newer endovenous technique is mechano-chemical ablation (MOCA) has been developed, using the ClariVein system. This technique uses intentional mechanical damage to the endothelium of the vene by means of a rotating catheter. At the same time a sclerosans is injected, and as a result the vene occludes. So this technique does not use heat technology. Tumescent anaesthesia is therefore not needed and complications related to techniques using heat (RFA and EVLA) such as burning, pain, hematoma, indurations, and paresthesia could be reduced or even be prevented.

MOCA proved to be a safe and effective alternative treatment for both insufficient great saphenous veins (GSV) and small saphenous veins (SSV). Especially for the treatment of the below-knee GSV and the treatment of superficial branches (such as the antero-lateral branches), there is a risk for damaging nerves that are in the close proximity of these veins.

In a series of 50 patients treated with EVLA for insufficient GSV above the knee, a technical success of 100% was reported after a median follow-up of 7 months, but this was accompanied by nerve damage in 8%. A recent study evaluating MOCA for the treatment of SSV reported an anatomical success of 96% without any nerve damage or other major complications. Therefore, MOCA could be an alternative for the treatment of various insufficient varicose vein segments without causing nerve damage.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic varicose veins, C2-C5
  • Ultrasound criteria:
  • Diameter supragenual great saphenous vein (GSV) >/= 12 mm , not tortuous; or
  • Insufficient antero-lateral branch; or
  • Insufficient below knee GSV
  • Signed informed consent
  • Patient consents to follow-up
  • Age > 18 year en < 80 year

排除标准

  • Patient is not capable to provide informed consent
  • Pregnancy and lactation
  • C6 varicose veins
  • Previous surgery or endovenous ablation at to treated segment
  • Deep venous vein thrombosis in medical history
  • Oral anti-coagulant therapy
  • Contra-indications or allergy for sclerosant
  • Immobilisation
  • Coagulant disorders or increased risk for thrombo-embolic complications: known coagulant disorders such as hemophilia A, hemophilia B, Von Willebrand disease, Glanzmann disease, factor VII-deficiency, idiopathic thrombo-cytopenic purpura, factor V Leiden disease and deep venous thrombosis or lung emboli in medical history
  • Fontaine III of IV peripheral arterial disease
  • Severe kidney disease: known GFR < 30 ml/min
  • Liver diseases accompanied by changes in coagulation of the blood, anamnestic indications for tendency towards haemorrhage , such as epistaxis and spontaneous hematoma, known liver cirrhosis

结局指标

主要结局

Clinical success

时间窗: 4 weeks + 1 year

CEAP, VCSS

Anatomical success

时间窗: 4 weeks + 1 year

Occlusion rate, evaluated using ultrasound scan

Peroperative pain

时间窗: Peroperative

VAS-score

Postoperative pain during 2 weeks post-treatment

时间窗: During 2 weeks post-treatment

VAS-score, used pain medication

次要结局

  • Postoperative complications(4 weeks + 1 year)
  • Duration of the intervention using MOCA(Peroperative)
  • Time to return to normal daily activities and work(Post-treatment)
  • Disease specific and general health status(4 weeks + 1 year)

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michel Reijnen

Vascular surgeon

Rijnstate Hospital

研究点 (1)

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