title: Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial.
abstract: OBJECTIVE
  The purpose of this study was to assess the safety and efficacy of the ClariVein(®) system that employs mechanochemical ablation of the great saphenous vein (GSV).
  
  
  METHODS
  Patients eligible for ablation of the GSV underwent micropuncture access with only local anaesthesia to insert a 4 or 5 Fr sheath. The ClariVein(®) catheter was placed through the sheath, the wire was extruded, and the distal tip of the wire positioned 2 cm from the saphenofemoral junction under ultrasound guidance. Catheter wire rotation was then activated for 2-3 seconds at approximately 3500 rpm. With the wire rotating, infusion of the sclerosant was started simultaneously with catheter pullback. The sclerosant used was 1.5% liquid sodium tetradecyl sulphate (Sotradecol(©), Bioniche Pharma Group, Geneva, Switzerland).
  
  
  RESULTS
  Thirty GSVs in 29 patients were treated. All patients have reached six-month follow-up; the average number of postoperative days is 260. No adverse events have been reported. The Primary Closure Rate is 96.7%.
  
  
  CONCLUSIONS
  Mechanochemical ablation appears to be safe and efficacious. The ClariVein(®) technique eliminates the need for tumescent anaesthesia. The great majority of incompetent GSVs can be treated with this technique.
authors.affiliation: Columbia Vein Programmes, Columbia University, New York, NY, USA.
authors.forename: S
authors.initials: S
authors.lastname: Elias
authors.forename: J K
authors.initials: JK
authors.lastname: Raines
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017115:Catheter Ablation / Q000295:instrumentation / Q000379:methods; D002908:Chronic Disease; D057510:Endovascular Procedures / Q000295:instrumentation / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012501:Saphenous Vein / Q000000981:diagnostic imaging; D012597:Sclerosing Solutions / Q000627:therapeutic use; D015911:Sclerotherapy / Q000295:instrumentation / Q000379:methods; D014463:Ultrasonography; D014648:Varicose Veins / Q000000981:diagnostic imaging / Q000628:therapy*
chemical_list: D012597:Sclerosing Solutions