Coronary Artery Stenosis Clinical Trial
Official title:
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) .
;
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