Coronary Artery Disease
Conditions
Keywords
significant stenosis (>70% of lumen stenosis), epicardial coronary arteries, clinical ischemic
Brief summary
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.
Interventions
DEVICEFirebird 2 sirolimus-eluting stent
the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
DEVICEExcel sirolimus-eluting stent
the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in-stent late lumen loss at 9 months' angiographic follow-up | 9 months | patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| target vessel failure | 2 years after index procedure | 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 \[PTCA\]). |
Countries
China
Outcome results
None listed