KCT0005960招募中未知
A prospective, multicenter, parallel, single-blind, randomized, pivotal study to evaluate the safety and efficacy of the everolimus eluting bioresorbable stent ‘BRSTM’ compared to 'XIENCETM' stent in patients with de novo coronary artery lesions.
Dotter0 个研究点目标入组 128 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 128
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •General inclusion criteria:
- •1.Subject must be at least 19 years of age.
- •2.Subject must suitable for percutaneous coronal intervention (PCI) and coronal artery bypass graft (CABG)
- •3.Subject must be with myocardial ischemia, such as angina and asymptomatic ischemia (except for vasospastic angina in accordance with the exclusion criteria 7).
- •4.Subject who voluntarily decides to participate in the clinical trial and agrees in writing
- •Angiographic inclusion criteria:
- •1. Subject must be with stenosis in the neoplasmic coronary lesion (a person with diameter stenosis of 50% or more under coronary angiography)
- •Location of the epicardial vessel with lesions: left anterior descending artery (LAD), left circumflex artery (LCX), right coronal artery (RCA)
- •2. In angiography, the subject’s diameter of the reference vessel is 2.5 mm or greater, 3.75 mm or less, and whose lesion length is 19 mm or less.
排除标准
- •An entity shall not be registered for clinical trials if any of the following exclusion criteria fall under:
- •Typical exclusion criteria:
- •1. The left ventricular lipolysis fraction (LVEF) is less than 30%
- •2. There is a history of bleeding tendency or blood clotting disorder
- •3. Life expectancy is less than 12 months
- •4. Subject with hypersensitivity or hypertensitivity to everolimus or structurally related compounds, aspirin, prasugrel, ticagrelor, heparin, poly(L-lactide)(PLLA), poly(D,L-lactide) (PDLLA), platinum(Platinum), cobalt, chromium, nichel, tungsten, acrylic, fluoropolymer, and contrast agents (but for contrast medium allergies, registration is possible if controlled by medication)
- •5. When accompanied by a cardiogenic shock
- •6. For secondary acute myocardial infarction (MI) for stent thrombosis
- •7. For vasospastic angina
- •8. Double antiplatelet therapy (DAPT) discontinued or discontinued treatment/surgery scheduled for 12 months after treatment
- •9. If fibrinolysis was performed prior to coronary artery intervention (PCI)
- •10. In case of PCI treatment (such as balloon angiography, stent, cutting balloon atherectomy) or lesions in vessels treated with brachytherapy within 12 months prior to the screening date
- •If a procedure is performed on a vessel other than the target vessel, it can be registered.
- •11. Patients with a history of cerebrovascular attack or transient ischemic attack (TIA) within six months prior to the screening date
- •12. Serum creatinine level = 2.5 mg/dL or dialysis
- •13. Platelet reading < 100,000 cells/mm3 or > 700,000 cells/mm3
- •14. Pregnant, nursing or women who plan to conceive within 12 months of treatment or who do not agree to use appropriate contraception for a period of 12 months
- •15. When clinically significant abnormalities (e.g. WBC=10000/uL) are found in haematological, hemochemical, urine tests, etc., which are laboratory tests performed at the time of screening or compromised immunity. However, registration is possible if the evaluation of this clinical trial is not affected by the tester's judgment.
- •16. Medical diseases (e.g. pneumonia, systemic infections, etc.) that show significant clinical impairments in cardiovascular, digestive, respiratory, endocrine, central nervous system, etc. or that have significant effects on this clinical trial.
- •17. Persons currently participating in other clinical trials. However, even if you have participated in other clinical trials in the past, you can register if the evaluation of this clinical trial is not affected by the tester's judgment.
- •18. Other situations in which the tester determines that it is not appropriate for this clinical trial or may increase the risk associated with participating in the clinical trial.
- •Angiographic exclusion criteria:
- •1. In case of re-enriched lesion
- •2. For distal occlusion
- •3. For lesions located in the saphenous vein graft.
- •4. If the bifurcation or ostial recess is at least 50% occluded in diameter,
- •5. If the lesion is in the left main coronary artery
- •6. If the lesion is within 3 mm of the RCA ostium recesses,
- •7. If the lesion is located within 3 mm of the trachea of the LAD or the left-line artery (LCX)
- •8. Anatomical structures of lesions that are not easily transmitted in BRSTM or XIENCE SierraTM stents
- •If the angulation is greater than 90° in the lesion area;
- •Two or more tortuosity of 45° or greater in the lesion area;
- •In case of severe calcification of the lesion area
- •9. Pre-dilation* fail
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