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Comparing the Safety and Efficacy of Cordimax and Xience V Drug-eluting Stents, for the Treatment of Coronary Heart Disease (CHD) in the Clinical Research of Real World
Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world. Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System
The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System. The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within vessel sizes \>= 2.5 mm and \<= 4 mm. All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT. All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Zhongshan Hospital Fudan University
Beijing, Beijing Municipality, China
Start Date
June 20, 2013
Primary Completion Date
June 20, 2019
Completion Date
June 20, 2020
Last Updated
June 14, 2017
3,660
ACTUAL participants
Cordimax
DEVICE
XIENCE V
DEVICE
Lead Sponsor
Shandong Branden Med.Device Co.,Ltd
Collaborators
NCT05831085
NCT05860400
Data Source & Attribution
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