Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug eluting stent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin target eluting stent | Device | Rapamycin target eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-stent late loss | In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years |
| Any myocardial ischemia (MI) |
Not provided
Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria:
Angiographic Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhi Xiong Zhong, MD | Meizhou Peple's Hospital in Guangdong Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meizhou Peple's Hospital | Meizhou | Guangdong | 514000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
percentage of participants that had any MI |
| 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years |
| Any revascularization | percentage of participants that had any revascularization | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years |
| Ischemia-driven TLR | percentage of participants that had Ischemia-driven TLR | 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 | 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) | 9 months |
| In-stent and in-segment binary restenosis rate | percentage of restenosis ≥50% in-stent or in-segment at 9 months post-procedure | 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 | 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. | 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. | 0 day |
| TLR | Including ischemia driven or non-ischemia driven | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years |
| target vessel revascularization (TVR) | Including ischemia driven or non-ischemia driven | 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 | 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 | 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. | 9 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided