title: Clarivein® mechano-chemical ablation an interim analysis of a randomized controlled trial dose-finding study.
abstract: OBJECTIVE
  The ClariVein® system is an endovenous technique that uses mechano-chemical ablation to treat incompetent truncal veins. This study was conducted to identify the ideal Polidocanol dosage and form for mechano-chemical ablation in order to occlude the great saphenous vein. When adhering to safe dosage levels, sclerosants with higher concentrations potentially limit the extent of treatment. It has been demonstrated that this problem may be overcome by using Polidocanol as a microfoam. This paper was established on findings of a preliminary analysis.
  
  
  METHODS
  The initial study was a single-blinded multicenter randomized controlled trial where patients are allocated to three treatment arms. Group 1 consisted of mechano-chemical ablation +2% Polidocanol liquid, group 2: mechano-chemical ablation +3% Polidocanol liquid and group 3: mechano-chemical ablation +1% Polidocanol foam
  
  
  RESULTS
  Eighty-seven, 34 males and 53 females (60.9%), mean age 55 years s.d. 16.0 (range 24-84), were enrolled in the study. Treatment length was 30 cm (range 10-30) for 95.2% of the patients. Mean operating time was 16 minutes (range 5-70). The mean saphenofemoral junction diameter (7.7 mm) was similar in all three groups. At 6 weeks post-treatment duplex ultrasound showed that 25 out of 25 = 100%, 27 out of 28 = 96.4% and 13 out of 23 = 56.5% were occluded in the mechano-chemical ablation + 2% Polidocanol liquid, mechano-chemical ablation + 3% Polidocanol liquid and mechano-chemical ablation + 1% Polidocanol microfoam respectively (p < 0.001). However, stricter scrutiny showed that the anatomical success rate defined as occlusion of at least 85% of the treated length to be 88.0%, 85.7% and 30.4% respectively (p < 0.001).
  
  
  CONCLUSIONS
  Mechano-chemical ablation using ClariVein® combined with 1% Polidocanol microfoam is significantly less effective and should not be considered as a treatment option of incompetent truncal veins. Further investigation to determine the ideal Polidocanol liquid dosage with mechano-chemical ablation is advocated and is being conducted accordingly.
authors.affiliation: Department of Vascular Surgery, Maastricht University Medical Centre, The Netherlands Department of Dermatology, Maastricht University Medical Centre, The Netherlands yeelai_1@hotmail.com.
authors.forename: Y L
authors.initials: YL
authors.lastname: Lam
authors.affiliation: Department of Vascular Surgery, Maastricht University Medical Centre, The Netherlands.
authors.forename: Irwin M
authors.initials: IM
authors.lastname: Toonder
authors.affiliation: Department of Vascular Surgery, Maastricht University Medical Centre, The Netherlands Department of Vascular Surgery, Universitätsklinikum Aachen, Germany.
authors.forename: Cees H A
authors.initials: CH
authors.lastname: Wittens
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077423:Polidocanol; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D012501:Saphenous Vein / Q000502:physiology / Q000503:physiopathology*; D014689:Venous Insufficiency / Q000473:pathology / Q000503:physiopathology* / Q000628:therapy*
chemical_list: D000077423:Polidocanol; D011092:Polyethylene Glycols
keywords: ClariVein; Varicose veins; foam; great saphenous vein; mechano-chemical ablation; mechanochemical ablation