A Phase 3 interventional study of Cordimax and XIENCE V in Coronary Artery Stenosis, sponsored by Shandong Branden Med.Device Co.,Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by Shandong Branden Med.Device Co.,Ltd · Phase 3, Interventional, and Treatment
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) .
302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.
This study's enrollment of 3,660 is above the median of 200 across 160 interventional studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →Shandong Branden Med.Device Co.,Ltd is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rapamycin Eluting Coronary Stent
Device: Cordimax
Everolimus Eluting Coronary Stent
Device: XIENCE V
One rapamycin eluting stent for treating the adapted coronary patients
One everolimus eluting stent for treating the adapted coronary patients
Target Lesion Failure(TLF)
including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization
Time frame: at 1st year
Thrombotic events incidence
According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d
Time frame: at30 60 90 days and 1st 2st 3st 4st 5st year
Major adverse cardiovascular events (MACE)
Events include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven
Time frame: at30 60 90 days and 1st 2st 3st 4st 5st year
The Success Rate of Stent Placement
The stent can arrive and through the target lesion area, and can be expanded finally.
Time frame: in the operation
Operation Success Rate
After stent implantation, stent diameter stenosis \< 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen.
Time frame: 0 to 24 hours after intervention
Cost of the hospitalization
The total expenses in the process of operation
Time frame: 0 to 24hours after discharge
Length of stay
The total time consumption in the process of operation
Time frame: 0 to 24 hours after discharge
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Shandong Branden Med.Device Co.,Ltd