NCT01121744已完成不适用
Supralimus-Core™ Pharmacokinetic (PK) Study: Evaluation of Pharmacokinetic (PK) and Safety of the Supralimus-Core™ Sirolimus Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Cmax, Tmax, AUC24h, AUClast, AUC∞, λz, t½term, CL
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetic (PK) and safety associated with Supralimus-Core™ Sirolimus Eluting Coronary Stent system in the treatment of single de novo lesions in native coronary arteries between 2.5 to 3.5 mm in diameter.
详细描述
This is a multi-centric, interventional, non-randomized, open label, Uncontrolled, single group assignment, Pharmacokinetics study. Approximately 20 patients will be enrolled in the study. Patients will be followed for 48 days post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with de novo native coronary artery lesions located in epicardial vessel who qualify for percutaneous coronary intervention will be included according to the inclusion and
排除标准
- •specified below:
- •Inclusion Criteria:
- •Age ≥18 years.
- •Eligible for percutaneous coronary intervention (PCI)
- •Acceptable candidate for CABG
- •Clinical evidence of ischemic heart disease and/or a positive territorial functional study. Documented stable angina pectoris ((Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C or IIIB-C), or documented silent ischemia.
- •The target lesion is a single de novo coronary artery lesion with ≥ 50% and < 100% stenosis in one of the major epicardial territories (LAD, LCX or RCA). A second target lesion in another major epicardial vessel could be treated and this second lesion should fit with the inclusion/exclusion criteria and will receive the same type of stent.
- •The target lesion must be covered by one study stent, preferably with a margin of 3 mm on each side of the lesion.
- •The target lesion must be ≤ 34 mm in length by visual estimate.
- •The target reference vessel diameter must be ≥ 2.5 mm and ≤ 3.5 mm.
- •Patient or patient's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as notified / approved by the Institutional Review Board/Ethics Committee of the clinical site.
- •Exclusion Criteria:
- •Female of childbearing potential
- •Documented left ventricular ejection fraction (LVEF) ≤ 25%
- •Evidence of an acute Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure
- •Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®, Ceruvin) or ticlopidine (Ticlid®), heparin, sirolimus, cobalt chromium, contrast agent (that cannot be adequately pre-medicated)
- •A platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC <3,000 cells/mm3
- •Acute or chronic renal dysfunction (creatinine >2.0mg/dl or >150µmol/L)
- •Target vessel has evidence of thrombus
- •Target vessel is excessively tortuous which makes it unsuitable for proper stent delivery and deployment
- •Previous bare metal stenting (less than 1 year) anywhere within the target vessel
- •Previous drug-eluting stenting anywhere within any epicardial vessel
- •The target lesion requires treatment with a device other than PTCA prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
- •Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run-off
- •Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated
- •Target lesion is located in or supplied by an arterial or venous bypass graft
- •Ostial target lesion
- •Patient is currently participating in an investigational drug or device study, including its follow-up period
- •Within 30 days prior to procedure, patient has undergone a previous coronary interventional procedure of any kind
- •Within 48 days post-procedure, patient requires planned interventional treatment of any non-target vessel. Planned intervention of the target vessel after the index procedure is not allowed.
- •CVA within previous 6 months
- •Unprotected Left Main (LM) coronary artery disease (stenosis >50%)
- •In the investigator's opinion, patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study
- •Planned surgery within 48 days after the index procedure
- •Life expectancy less than 1 year
- •Any contraindication to blood sampling
结局指标
主要结局
Cmax, Tmax, AUC24h, AUClast, AUC∞, λz, t½term, CL
时间窗: Up to 48 days
次要结局
- Major Adverse Cardiac Event (MACE)(Up to 48 days)
研究者
研究点 (8)
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