NL-OMON41034已完成4 期
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) - MOCA-X
Rijnstate Ziekenhuis0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Symptomatic varicose veins, C3-C5
- •2. Ultrasound criteria:
- •a. Diameter supragenual great saphenous vein (GSV) >/= 12 mm , not tortuous; or
- •b. Insufficient antero-lateral branch <12 mm; or
- •c. Insufficient below knee GSV < 12 mm
- •3. Signed informed consent
- •4. Patient consents to follow-up
- •5. Age > 18 year en < 80 year
排除标准
- •1. Patient is not capable to provide informed consent
- •2. Pregnancy and lactation
- •3. C6 varicose veins
- •4. Previous surgery or endovenous ablation at to treated segment
- •5. Deep venous vein thrombosis in medical history
- •6. Oral anti-coagulant therapy
- •7. Contra-indications or allergy for sclerosant
- •8. Immobilisation
- •9. Coagulant disorders or increaased risk for thrombo-embolic complications: known coagulant disorders such as hemofilia A, hemofilia 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
- •10. Fontaine III of IV peripheral arterial disease
- •11. Severe kidney disease: known GFR < 30 ml/min.
- •12. Liver diseases accompanied by changes in coagulation of the blood, anamnistic indications for tendency towards haemorrhage , such as epistaxis and spontanuous hematoma, known liver cirrhosis.
研究者
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