Comparison of 1% and 3% Polidocanol Foam in Ultrasound Guided Sclerotherapy of the Great Saphenous Vein: A Randomised, Double-Blind Trial with 2 Year-Follow-up. “The 3/1 Study”

Hamel-Desnos, C; Ouvry, P.; Benigni, J. P.; Boitelle, G.; Schadeck, M.; Desnos, P.; Allaert, François-André

doi:10.1016/j.ejvs.2007.07.014

Cited by 104 publications

(23 citation statements)

References 16 publications

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“…Although there are no published outcomes studies of Varisolve ® comparing polidocanol concentrations, two studies have compared outcomes in sclerotherapy treatment of great saphenous vein reflux using air-based 1% and 3% polidocanol foam in either 80 [34] or 148 [35] patients. At long duration after treatment (one year or greater), both studies revealed equivalent efficacy for the two doses to abolish reflux.…”

Section: Clinical Efficacymentioning

confidence: 99%

Polidocanol for endovenous microfoam sclerosant therapy

Eckmann¹

2009

Expert Opinion on Investigational Drugs

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Background-Polidocanol is a liquid surfactant having endothelial cell lytic properties. In the form of a controlled, dispensed microfoam it is administered endovenously as a sclerosing agent in the treatment of varicose veins.Objective-This review summarizes efficacy of polidocanol endovenous microfoam sclerotherapy using a proprietary dispensing system to control foam characteristics and gas content for treating varicose veins. Methods-We reviewed in-vitro, Phase I, Phase II and limited Phase III data for polidocanol microfoam with a focus on controlled foam formulation in therapyResults/conclusions-Clinical trials of controlled dispensing of polidocanol microfoam provide evidence of effective treatment of chronic venous insufficiency with low toxicity, minimal risk and few complications.

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Section: Clinical Efficacymentioning

confidence: 99%

Polidocanol for endovenous microfoam sclerosant therapy

Eckmann¹

2009

Expert Opinion on Investigational Drugs

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“…6 While foam sclerotherapy does obviate the necessity for tumescent anaesthesia, efficacy rates are lower than endothermal ablation and reported complication rates are higher. 7,8 At present, it cannot be stated that foam sclerotherapy is as efficacious as endothermal ablation.…”

Section: Introductionmentioning

confidence: 99%

Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial

2011

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ObjectiveThe 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).MethodPatients 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).ResultsThirty 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%.ConclusionMechanochemical 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.

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“…Frullini and Cavezzi showed foam sclerotherapy is equally applicable in complicated and uncomplicated venous disease (19). Rapid healing of ulcers following foam sclerotherapy was reported in some clinical researches and it confirmed that this treatment could probably achieve the same outcomes that result from saphenous obliteration in leg ulcer patients (20)(21)(22)(23)(24)(25)(26)(27).…”

Section: Discussionmentioning

confidence: 85%

Outcome of Ultrasonography-Guided Foam Sclerotherapy Versus Stab Avulsion Ambulatory Phlebectomy in the Treatment of Varicosis in Small Veins of the Leg: A Single Blinded Randomized Clinical Trial

et al. 2017

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Comparison of 1% and 3% Polidocanol Foam in Ultrasound Guided Sclerotherapy of the Great Saphenous Vein: A Randomised, Double-Blind Trial with 2 Year-Follow-up. “The 3/1 Study”

Abstract: This study demonstrates equivalent efficacy for 1% POL and 3% POL foam in sclerotherapy of the GSV where the trunk is less than 8 mm in diameter. These data obtained two years of follow-up confirm our previously reported 6 month-follow-up data published in 2005.

Cited by 104 publications

References 16 publications

Polidocanol for endovenous microfoam sclerosant therapy

Polidocanol for endovenous microfoam sclerosant therapy

Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial

Outcome of Ultrasonography-Guided Foam Sclerotherapy Versus Stab Avulsion Ambulatory Phlebectomy in the Treatment of Varicosis in Small Veins of the Leg: A Single Blinded Randomized Clinical Trial

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