The aim of the TARGET PREMIER trail in to demonstrate the safety and efficacy of the rapamycin target eluting stent in the treatment of subjects with ischemic heart disease (asymptomatic myocardial ischemia , table or unstable angina), with target lesion(s) in coronary arteries with visually estimated reference vessel diameter ≥2.25mm and ≤4.0 mm.
200 participants with coronary artery stenosis will enrolled in the investigation to receive PCI surgery treatment with rapamycin target eluting stent implantation. All the participants will get clinical follow-up after PCI surgery within 30 days, 6 months, 9 months, 12 months and 2-5 years, and they will be conducted coronary angiogram at 9th month after PCI to get the data of in-stent late loss which was the main endpoint of the investigation. The secondary endpoints including device sucess, operation success, clinical sucess, Doce, PoCE, TLR, TVR, MI incident rate, death, stent thrombosis as defined by ARC, stent retraction, MLD, DS and ARB. The data derived from the investigation will be performed statistic analysis to evaluate whether the clinical outcome meet the PG.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Rapamycin target eluting stent
Meizhou Peple's Hospital
Meizhou, Guangdong, China
In-stent late loss
In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
Time frame: 9 months
Target Lesion Failure
Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated)
Time frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
Any myocardial ischemia (MI)
percentage of participants that had any MI
Time frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
Any revascularization
percentage of participants that had any revascularization
Time frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
Ischemia-driven TLR
percentage of participants that had Ischemia-driven TLR
Time frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
Probable and definite stent thrombosis defined by Academic Research Consortium (ARC)
percentage of participants that had probable and definite stent thrombosis
Time frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
Late lumen loss in segment
Late Lumen Loss in segment at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
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Time frame: 9 months
In-stent and in-segment binary restenosis rate
percentage of restenosis ≥50% in-stent or in-segment at 9 months post-procedure
Time frame: 9 months
Device success
Device Success is defined as a final residual diameter stenosis of \<30%, thrombolysis in myocardial infarction (TIMI) 3, by QCA, using the assigned device only
Time frame: 0 day
Procedure success
Procedure Success defined as achievement of a final diameter stenosis of \<30%, TIMI 3, by QCA, using any percutaneous method, without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay.
Time frame: During the hospital stay to a maximum of the first seven days post index procedure
Target lesion success
Target lesion success defined as achievement of a final diameter stenosis of \<30%, TIMI 3, by QCA, using any percutaneous method.
Time frame: 0 day
TLR
Including ischemia driven or non-ischemia driven
Time frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
target vessel revascularization (TVR)
Including ischemia driven or non-ischemia driven
Time frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
Patient oriented composite endpoint (PoCE)
defined as all death, all MI and any revascularization
Time frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
In-stent and in-segment %diameter stenosis (%DS)
In-stent and in-segment %diameter stenosis (%DS) at 9 months post-procedure as measured by QCA
Time frame: 9 months
In-stent and in-segment minimum lumen diameter
In-stent and in-segment minimum lumen diameter at 9 months post-procedure as measured by QCA.
Time frame: 9 months