Registry of the treatment of primay insufficiency of the great saphenousvein with a diameter >/= 12 mm, anterolateral branches, or greatsaphenous vein insufficiency below the knee with mechano-chemicalendovenous ablation (MOCA) - MOCA-X

Rijnstate0 个研究点目标入组 90 人开始时间: 2014年11月19日最近更新: 2018年1月22日

适应症

试验速览

暂无简介。

•1.Symptomatic varicose veins, C2-C5
•2.Ultrasound criteria:
•a.Diameter supragenual great saphenous vein (GSV) >/= 12 mm , not tortuouss; or
•b.Insufficient antero-lateral branch; or
•c.Insufficient below knee GSV
•3.Signed informed consent
•4.Patient consents to follow-up
•5.Age > 18 year en < 80 year
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•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.

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