Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.
The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
AeroSpace center hospital
Beijing, China
the second hospital of Jilin Unversity
Changcun, China
Daqing General Oil Field Hospital
Daqing, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, China
Technical Success Rate
Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
Time frame: 1 day
Target Lesion Revascularization (TLR) Rate
Time frame: 30 days
Target Lesion Failure (TLF) Rate
Time frame: 30 days
Target Vessel Revascularization (TVR) Rate
Time frame: 30 days
Target Vessel Failure (TVF) Rate
Time frame: 30 days
Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
Time frame: 30 days
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The First Hospital of Lanzhou University
Lanzhou, China
General Hospital of SY Military Institute
Shenyang, China
TEDA International Cardiovascular Hospital
Tianjin, China
Wuhan Asia Heart Hospital
Wuhan, China