China Made Sirolimus Eluting Stent for Intermediate Lesion

Study Overview
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Brief Summary
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Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.

Official Title
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China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: China-made SES (Firebird 2 and Excel)
* Other: routine medicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 years old both gender native coronary lesion narrowing 50-70% vessel size 2.5-4.0 in diameter Exclusion Criteria: without informed consent, ST elevation myocardial infarction within 7 days, left main lesion, by-pass graft, restenosis abnormal liver function before randomization, active hepatitis or muscular disease, impaired renal function with serum creatinine level > 3mg/dl , impaired left ventricular function with LVEF < 30%, participate in other studies.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SES<br>including two types of China-made SES, i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent). | Device: China-made SES (Firebird 2 and Excel)<br>* patients with coronary 50-70% narrowing treated with China-made SES stent,i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).<br>|
| Other: medicine<br> | Other: routine medicine<br>* patients with coronary 50-70% narrowing treated with routine medicine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target vessel failure | defined as the occurrence of any of the following within 12 months after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularization of the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac events | including cardiac death, re-infarction and target vessel revascularization. | 12 months |