Coronary Artery Disease, Coronary Stenosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERapamycin target eluting stent
Rapamycin target eluting stent
Sponsors
Shanghai MicroPort Medical (Group) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Patient with an indication for percutaneous coronary intervention (PCI) including silent ischemia (in absence of symptoms a positive functional study or a reversible change in the ECG consistent with ischemia), angina (stable or unstable). 3. Subject acceptable candidate for coronary artery bypass surgery (CABG). 4. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic Inclusion Criteria: 1. Treatment up to two target lesions with a maximum of two lesions per epicardial vessel. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 10mm apart per visual estimation. 2. Target lesion(s) must be located in a native coronary artery with a visually estimated diameter stenosis ≥70%, TIMI 1, lesions length ≤36mm. Target vessel must be visually estimated diameter of ≥2.25mm to ≤4.0mm. 3. Target lesion must be adequately covered with a single stent. 4. Up to two target lesion needed treatment in one target vessel. 5. One non-target lesion is allowed prior to enrollment if successful. It should be located at the distal end of the target lesion, and be at lease 10mm apart, when both are in the same epicardial vessel.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent late loss | 9 months | In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any myocardial ischemia (MI) | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years | percentage of participants that had any MI |
| Any revascularization | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years | percentage of participants that had any revascularization |
| Ischemia-driven TLR | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years | percentage of participants that had Ischemia-driven TLR |
| Probable and definite stent thrombosis defined by Academic Research Consortium (ARC) | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years | percentage of participants that had probable and definite stent thrombosis |
| Late lumen loss in segment | 9 months | Late Lumen Loss in segment at 9 months post-procedure as measured by quantitative coronary angiography (QCA) |
| In-stent and in-segment binary restenosis rate | 9 months | percentage of restenosis ≥50% in-stent or in-segment at 9 months post-procedure |
| Device success | 0 day | 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 |
| Target Lesion Failure | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years | 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) |
| Target lesion success | 0 day | Target lesion success defined as achievement of a final diameter stenosis of \<30%, TIMI 3, by QCA, using any percutaneous method. |
| TLR | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years | Including ischemia driven or non-ischemia driven |
| target vessel revascularization (TVR) | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years | Including ischemia driven or non-ischemia driven |
| Patient oriented composite endpoint (PoCE) | 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years | defined as all death, all MI and any revascularization |
| In-stent and in-segment %diameter stenosis (%DS) | 9 months | In-stent and in-segment %diameter stenosis (%DS) at 9 months post-procedure as measured by QCA |
| In-stent and in-segment minimum lumen diameter | 9 months | In-stent and in-segment minimum lumen diameter at 9 months post-procedure as measured by QCA. |
| Procedure success | During the hospital stay to a maximum of the first seven days post index procedure | 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. |
Countries
China
Outcome results
None listed