CiloTax StentTM - summitMD.com

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Study Design • Prospective randomized study 110 patients, 2 Korea centers (AMC &CMC) • Inclusion criteria: - de novo lesion ≤ 20 mm in length - reference diameter ≥ 2.5 mm and ≤ 3.5 mm • Study devices: - Cilotax (Cardiotec Co.): 3.0, 3.5 & 18 mm (23 mm) - Taxus (Boston Scientific Co.): 3.0, 3.5 & 20 (24 mm) • Repeat angiography and IVUS at 8 months All patients to be followed clinically up to 12 months
Study Endpoints • Statistics - a sample of 110 patients to detect a difference in the mean late loss of 0.2 mm between the two groups, assuming a standard deviation of 0.4 mm in each group & 80% power. • Primary endpoint - in-segment late loss at 8 months (QCA) Secondary endpoint - stent thrombosis & MACE at 8 months - restenosis and TLR at 8 months - diameter stenosis at 8 months (QCA) - % in-stent volume obstruction at 8 months (IVUS)
Page 1 and 2: CiloTax Stent TM Dual Drug-eluting
Page 3 and 4: Moving Forward Co-drug Eluting Sten
Page 5 and 6: A Potent Anti-platelet Agent Effect
Page 7 and 8: Anti-restenotic Effect DECLARE - Lo
Page 9 and 10: The Ideal Combination? Cilotax TM S
Page 11 and 12: Cilotax Stent TM Polymer & Drugs Po
Page 13 and 14: Safety and Efficacy of the Cilotax
Page 15 and 16: Animal Preparation • Juvenile swi
Page 17 and 18: Analysis • Angiography and IVUS:
Page 19 and 20: Results 3.0 18mm Cilotax BMS 4 week
Page 21 and 22: IVUS Analysis at Follow-Up (n=7) BM
Page 23 and 24: Results BMS (n=3) Cilotax stent (n=
Page 25 and 26: Results Inflammatory Response BMS (
Page 27 and 28: Clinical Study Efficacy and Safety
Page 29: Objectives • to assess safety and

CiloTax StentTM - summitMD.com

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