Endeavor 在中国临床试验的案例分析PPT.ppt

FWH’s Clinical Research Team Cultivate research atmosphere through continuous clinical study training and participation in high standard clinical trials Clearly define roles and responsibilities to ensure accountability Clinical Study Cath Lab Director Cath Lab Operators Study Coordinator appointed from the physician group Technicians for QCA CD making Dedicated Study F/U Team Cath Lab Nurses for Data Entry Top Quality Work Wins Credibility in True Global Clinical Trials Ensure that the whole research team receives comprehensive training on any specific study Dedicated study coordinator and clearly defined roles and responsibilities to enforce accountability Following the global standard on good clinical practice Impressive patient enrollment pace provided study data quality is not compromised Prospective, Multicenter Registry AssessingSafety in a Real World Chinese Patient Population China Endeavor Registry (Endeavor-China) Primary Endpoint: MACE at 12 months Secondary Endpoints: MACE at 30 days and 6 mo, Stent thrombosis, procedure success rate; device success rate; lesion success rate Drug Therapy: ASA and Clopidogrel 3 monthsZotarolimus Dose: 10 ?g per mm stent length Single and Multiple Coronary Artery Lesions Stent Diameters: 2.25-4.0 mm Stent Length: 8/9-30 mm N = 2,200 patients 32 sites across China Clinical/MACE 30d 6mo 2yr* 12mo *Limited number of centers and specific patient subset. Goals of Endeavor China Registry 通过入选“真实世界”中国病人以扩展对Endeavor支架的临床认识 To expand the clinical knowledge base for Endeavor stent delivery system by including ‘real world’ patients in China 评估在中国病人中对主要不良心脏事件高危患者临床事件的发生率，如糖尿病、小血管及长病变病人 To assess the event rate in Chinese patients known to have a higher risk of major adverse cardiac events, for example patients with diabetes mellitus, small vessels and long lesions China Endeavor Registry Sample Size Calculation The primary endpoint is the Major Adverse Cardiac Events (MACE) rate at 1 year post-procedure. This