Phlebology
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Randomized Controlled Trial Multicenter Study
The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence.
VANISH-2 Investigator Group: K Gibson, Bellevue, WA, USA; M Goldman, San Diego, CA, USA; P Hertzman, Los Alamos, NM, USA; S Hirsch, Pittsburgh, PA, USA; R Hye, San Diego, CA, USA; M Isaacs, Walnut Creek, CA, USA; M Plaza-Ponte, Monroeville, PA, USA; S Rathbun, Oklahoma City, OK, USA; J Rhodes, Rochester, NY, USA; G Rosenberg, Frederick, MD, USA; M Schul, Lafayette, IN, USA; M Stanbro, Greenville, SC, USA; and R Weiss, Hunt Valley, MD, USA To determine efficacy and safety of polidocanol endovenous microfoam in treatment of symptoms and appearance in patients with saphenofemoral junction incompetence due to reflux of the great saphenous vein or major accessory veins. ⋯ Polidocanol endovenous microfoam provided clinically meaningful benefit in treating symptoms and appearance in patients with varicose veins. Polidocanol endovenous microfoam was an effective and comprehensive minimally invasive treatment for patients with a broad spectrum of vein disease (clinical, etiology, anatomy, pathophysiology clinical class C2 to C6) and great saphenous vein diameters ranging from 3.1 to 19.4 mm. Treatment with polidocanol endovenous microfoam was associated with mild or moderate manageable side effects. VVSymQ is an important new, validated instrument for symptom assessment in patients with varicose veins.