Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai) with durable polymer, comparing with Excel SES.

Official Title
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Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Firebird 2 sirolimus-eluting stent
* Device: Excel sirolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years male or un-pregnant female stenosis > 70% in one of major the epicardial coronary arteries no contra-indications of stent implantation singed the informed consent Exclusion Criteria: acute myocardial infarction within one week have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy no history of stent implantation within last one-year received other brand coronary stent during index procedure with no achievement of informed consent

Ages Eligible for Study
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Minimum Age: 18 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: Firebird 2 stent group<br>the patients who receive Firebird 2 stent | Device: Firebird 2 sirolimus-eluting stent<br>* the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform<br>|
| Active Comparator: Excel stent group<br>the patients who receive Excel stent | Device: Excel sirolimus-eluting stent<br>* the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-stent late lumen loss at 9 months' angiographic follow-up | patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target vessel failure | defined as the occurrence of any of the following within 1 and 2 years after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularizationof the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]). | 2 years after index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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significant stenosis (>70% of lumen stenosis), epicardial coronary arteries, clinical ischemic