NCT03624205Unknown不适用
To Evaluate the Long Term Safety and Efficacy of Drug Coated Balloon SeQuent® Please in Chinese Coronary Instent Restenosis Patients,a Prospective, Multi-center,Randomization Clinical Trial.
B. Braun Medical International Trading Company Ltd.0 个研究点目标入组 520 人开始时间: 2015年4月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 520
- 主要终点
- Target Lesion Failure in 12 months after operation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria related to subjects
- •At the age of 18-80, Both male and female;
- •Patients with coronary In sentrestenosis and suitable for the theory of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）, no more than 1 target lesion in each coronary artery
- •After pre-dilation of target lesion, the residual stenosis is ≥ 30% , patients with type B dissection
- •Patients must agree to sign the ICF and to undergo the clinical follow-up at 30 days, 6 months, 6 months, 12 months, 24 months, 36months, 48 months and 60 months after operation Criteria related to lesions
- •The target lesion length and target vessel diameter should be consistent with the instructions of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）
排除标准
- •Criteria related to subjects
- •Women with pregnancy or lactation
- •Patient with cardiac shock
- •Patients with Hemorrhagic physique or active gastrointestinal ulcers, with cerebral apoplexy or transient cerebral ischemia within 3 months, who couldn't be tolerated the expected aspirin and/or clopidogrel theory
- •Patients with severe valvular heart disease
- •Patients with severe congestive heart failure or NYHA class IV heart failure;
- •Patients who have received heart transplant;
- •Patients with life expectancy more than 60 months, or those who is difficulties in clinical follow-up.
- •Patients who are currently involved in any other clinical trial;
- •Patients that the investigators think that those are not suitable Criteria related to lesions
- •Chronic total occlusion
- •Lesion that cannot be treated with PTCA or other interventional techniques;
- •The vessel diameter < 2.25 mm
- •Left main disease needed to be treated Exclusion criteria related to concomitant medication
- •Patients who are intolerant to aspirin and/or clopidogrel or have a history of neutrophilopenia or thrombocytopenia, or patients with severe hepatic insufficiency and contraindicated for clopidogrel.
- •Patients who are known to be intolerant or allergic to heparin, contrast agent, paclitaxel, iopromide, rapamycin, polylactic acid - glycolic acid polymer, stainless steel;
结局指标
主要结局
Target Lesion Failure in 12 months after operation
时间窗: 1 year
To measure Target Lesion Failure in 12 months by using angiography
次要结局
未报告次要终点
研究者
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