Cordimax China Post Market Surveillance

Study Overview
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Brief Summary
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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

Detailed Description
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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) .

Official Title
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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

Conditions
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Coronary Artery Stenosis

Intervention / Treatment
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* Device: Cordimax
* Device: XIENCE V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years old or more patients with symptomatic coronary artery disease adapt to the DES treatment according to guide with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5 4.0 mm) in diameter ;has the objective basis of myocardial ischemia patients willing to participate and sign in research Exclusion Criteria: Women in pregnancy or lactation Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation Patients were banned to use the antiplatelet and/or anticoagulant therapy Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project Patients who must stop clopidogrel to accept a elective surgery patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cordimax<br>Rapamycin Eluting Coronary Stent | Device: Cordimax<br>* One rapamycin eluting stent for treating the adapted coronary patients<br>|
| Active Comparator: XIENCE V<br>Everolimus Eluting Coronary Stent | Device: XIENCE V<br>* One everolimus eluting stent for treating the adapted coronary patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure(TLF) | including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization | at 1st year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 0 to 24 hours after intervention | 
| Cost of the hospitalization | The total expenses in the process of operation | 0 to 24hours after discharge | 
| Length of stay | The total time consumption in the process of operation | 0 to 24 hours after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents Coronary Artery Disease