1、以高品质在真正的世界级临床试验中建立声誉： Endeavor 在中国临床试验的案例分析Top Quality Work Wins Credibility in True Global Clinical Trials - A Case Study of Endeavor Clinical Programs in China阜外心血管病医院介入导管室徐 波Story Flow1. Medtronic global Endeavor clinical program overview, to highlight E-five, PROTECT, China Endeavor Registry, th
2、ree studies China has been participating in2. More information on E-five, FWHs performance in E-five3. More information on PROTECT, FWHs performance in PROTECT (AP newsletter snapshot and Global newsletter snapshot reflecting recognition on FWHs performance)4. Summarize what FWH has done right in th
3、e above global trials to establish a good reputation on clinical study5. Introducing China Endeavor Registry (CER), use what FWH has done right in E-five and PROTECT to encourage sites participating in CER to speed up patient enrollment while ensuring data qualityRandomized Clinical Study Organizati
4、on AnatomyStudy Management TeamStudy SitesSponsorCRAs*/MonitorsRandomization SystemData Management device success rate; lesion success rateDrug Therapy: ASA and Clopidogrel 3 monthsZotarolimus Dose: 10 g per mm stent lengthSingle and Multiple Coronary Artery LesionsStent Diameters: 2.25-4.0 mmStent
5、Length: 8/9-30 mm N = 8,000 patients200 sitesEurope, Asia Pacific, Israel, South AmericaClinical/MACE30d 6mo 2yr*12mo*Limited number of centers and specific patient subset.E-five Study Organization AnatomyMedtronic Clinical DepartmentStudy SitesSponsorMedtronicCRAs/MonitorsE-CRF SystemData Managemen
6、t & Statistical AnalysisCore LabsCECE-Five Registry(Recent) MI (%)Non Q-wave MIQ wave MIPrior CABG (%)Unstable Angina (%)Diabetes Mellitus (%)Prior PCI (%)Prior MI (%)Age (years)Male Gender (%)n = 8318 PatientsPatient Demographics of total registry76.763.3011.0632.112.221.425.37.532.721.834.0E-Five
7、Registryn=8318 patients and 10343 lesionsLAD (%) 46.6B2/C Lesions (%) 60.3RVD (mm) 2.930.47Lesion Length (mm) 18.5010.60Pre-procedure MLD (mm) 0.500.41Pre-procedure DS (%) 82.8413.51Post-procedure DS (%) 2.418.24Baseline Angiography of total registry (visual measurement)E-Five Registry21.2(Recent) MI (%)12.2Non Q-wave MI25.3Q wave MI7.0Prior CABG (%)31.2Unstable Angina (%)34.4Diabetes Mellitus (%)23.9Prior PCI (%)35.9Prior MI (%)62.9511.46Age (years)76.9Male Gender (%)n = 1989 patientsPatient Demographics 1989 patients
