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خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

Summary of pivotal studies to qualify for FDA approval

Summary of pivotal studies to qualify for FDA approval
Technique Study Study endpoint Closure rate Adverse events
RFA Proebstle[1] 6 months 99.6%

DVT: 0%

Paresthesia: 3.2%

Phlebitis: 0.8%
VeClose Trial[2] 3 months 96%

DVT: 0%

Paresthesia: 3%

Phlebitis: 3%
Laser ablation Min[3] 2 years 93.4%

DVT: 0%

Paresthesia: 1.1%
PEM (1% POL) VANISH-1[4] 8 week closure rate with 1% polidocanol 80.4%

DVT: 1.9%

Phlebitis: 7.7%
VANISH-2[5] 86.2%  
MOCA Elias[6] 6 months 96.7% No PE or CVA events
Cyanoacrylate glue VeClose Trial 3 months 99% VenaSeal

DVT: 0%

Paresthesia: 3%

Phlebitis: 4%
FDA: Food and Drug Administration; RFA: radiofrequency ablation; DVT: deep vein thrombosis; PEM: polidocanol endovenous microfoam; POL: polidocanol; MOCA: mechanical occlusion with chemical assistance; PE: pulmonary embolism; CVA: cerebrovascular accident.
References:
  1. Proebstle TM, Vago B, Alm J, et al. Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: First clinical experience. J Vasc Surg 2008; 47:151.
  2. Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg 2015; 61:985.
  3. Min RJ, Zimmet ST, Isaacs MN, Forrestal MD. Endovenous laser treatment of the incompetent greater saphenous vein. J Vasc Interv Radiolology 2001; 12:1167.
  4. King JT, O'Byrne M, Vasquez M, et al. Treatment of truncal incompetence and varicose veins with a single administration of a new polidocanol endovenous microfoam preparation improves symptoms and appearance. Eur J Vasc Endovasc Surg 2015; 50:784.
  5. Todd KL 3rd, Wright DI, VANISH-2 Investigator Group. 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. Phlebology 2014; 29:608.
  6. Elias S, Raines JK. Mechanochemical tumescentless endovenous ablation: Final results of the initial clinical trial. Phlebology 2012; 27:67.
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