NCT01909869已完成不适用
A PILOT First-In-Man Study to Evaluate Safety and Efficacy of the EXCEL-Ⅱ With Cobalt Chromium Alloys Sirolimus Eluting Biodegradable Polymer Stent in the Treatment of Patients With de Novo Coronary Artery Lesions(CREDIT-I)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Primary endpoint(MACE)
研究概览
简要总结
One of the purpose of this study is to assess the preliminary safety and feasibility,and to provide related information and evidence for the design of the further pivotal randomized control trial.the other purpose is to assess the performace of the stent delivery system.
详细描述
- Single-center, prospective, pilot study
- De novo,coronary artery, single vessel and single lesion
- Sample size = 45
- Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years
- Randomization 2:1 Angio and OCT scheduled follow-up in the hospital
- Follow-up Angio and OCT randomized 30 patients for 4-month and 15 patiens for 12-month
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18yrs≤Age≤75yrs .
- •De novo lesion at native coronary artery.
- •Single target vessel and single target lesion.
- •Lesion length ≤32mm.
- •RVD 2.5mm～4.0mm.
- •DS%≥70% by visual estimation.
- •Target lesion could be covered by only one stent.
- •Subjects are willing to follow the specified requirements follow-up.
- •A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
排除标准
- •AMI within one week.
- •CTO(TIMI0),LM lesion,ostial lesion,graft vessel lesion,bifurcation (side branch RVD≥2.5mm),ISR,mutivessel disease need to be treated.
- •Severe calcified lesion unable to predilate.
- •extremely tortuous proximal to the lesion that is inadequate to stent delivery.
- •NYHA≥Ⅲ or LVEF≤40%.
- •Prior stenting within 1 year.
- •Pregnancy or lactation, and plan in postoperative pregnancy or lactation.
- •Subjects had bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue DAPT healers at least 1 year.
- •There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
- •To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
- •Serious liver and kidney function is not complete person.
- •The investigators think that do not fit to enroll the study.
研究组 & 干预措施
EXCEL-Ⅱ
Experimental
A new Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions.
干预措施: EXCEL-Ⅱ (Device)
结局指标
主要结局
Primary endpoint(MACE)
时间窗: 30days(MACE)
Device oriented cardiovascular endpoint at 30-day (MACE) defined as the composite of Cardiac Death,Myocardial Infarction(Q and non-Q) or Ischemia-driven Target Lesion Revascularization
次要结局
- Secondary endpoint(5 years (Follow-up))
研究者
研究点 (1)
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