Study of Resolute Coronary Stent System in Treating Diabetic Coronary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 12-month TVF occurrence
研究概览
简要总结
Resolute zotarolimus-eluting stent (ZES) system (Medtronic, USA) has been world-wildly used in treating patients with coronary artery disease (CAD). The State Food and Drug Administration of China has approved qualification of RESOLUTE zotarolimus-eluting stent system in 2010. It has been reported that RESOLUTE stent may be more suitable for DM patients and FDA has approved diabetic coronary lesion as a indication for using Resolute stent. Here the investigators set out a multicenter, non-inferiority study: the efficacy and safety of RESOLUTE zotarolimus-eluting stents in treatment of Chinese diabetes (RESOLUTE-DIABETES CHINA) in purpose of identifying the efficacy and safety in Asia CAD correlated with diabetic population.
详细描述
STUDY DESIGN This study is a multicenter registry held in China main land. A total of 1,000 diabetic patients with coronary artery disease and receive RESOLUTE zotarolimus eluting stents implantation from 20 study centers will be enrolled. The estimated follow-up duration is 12-month. Clinical events, laboratory examination results and related data will be recorded in the time point of 30 days, 6-month and 12-month. Patients who quit half-way cannot be replaced and the reasons should be reported.
All data collection and management, analysis and supervision will be accomplished by independent study institution.
STUDY POPULATION All 1,000 patients enrolled in this registry and receive RESOLUTE zotarolimus eluting stents implantation should be diagnosed as type 2 diabetes previously or during hospital before PCI procedure. Glucose level (fast and 2h post-meal), HbA1c and all medications should be recorded before enrollment and all through follow-up period.
STUDY DURATION The estimated follow-up duration is 12-month. Clinical events, laboratory examination results and related data will be recorded in the time point of 30 days, 6-month and 12-month.
STUDY PROCESS Patients sign the informed consent and should be provided with a signed and dated copy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as type 2 diabetes before PCI procedure (Supervised by center study institution) RESOLUTE zotarolimus eluting stents are the proper selection according to researcher's opinion.
- •Patient or guardian has signed the informed consent.
排除标准
- •Women during gestation or lactation. Bypass vessel disease after coronary artery bypass grafting (CABG). Any other brand of coronary artery stent has been implanted. Patients with impaired fast glucose level (6.0mmol/L-7.0mmol/L) or impaired carbohydrate tolerance (OGTT 2h glucose level within 7.8mmol/L-11.1mmol/L).
- •Any non-balloon vascularization or intra-vessel radiation has been used. Expected life bellow 12 months. Allergy to aspirin, clopidogrel, heparin, stainless steel, contrast medium or zotarolimus.
- •Recently attend any other medication research or medical instrument research that possibly interfere RESOLUTE diabetes study.
- •Researcher declines the property of RESOLUTE zotarolimus eluting stent implantation.
- •Patients who cannot agree with the study protocol or cannot understand the peculiarity, circumscription and possible consequence so that the informed consent, clinical follow-up and the research process cannot be conducted.
研究组 & 干预措施
Resolute stent treatment group
All patients will receive Resolute stent implantation to cure severe coronary atherosclerotic lesions.
RESOLUTE stent system specification (eluted zotarolimus 1.6μg/mm2):
After stent implantation, each patient will be followed up at time point of 30-day, 6-month and 12-month.
Follow-up window:
Duration of hospital stay Follow-up 1: 30days after procedure (±7 days) Follow-up 2: 6-month after procedure (±30 days) Follow-up 3: 12-month after procedure (±30 days)
干预措施: Resolute stent treatment (Device)
结局指标
主要结局
12-month TVF occurrence
时间窗: 12-month
TVF definition 1. Cardiac death (CD) 2. Occurrence of myocardial infarction (Q wave or non-Q wave) in heart wall related to previously RESOLUTE stent treated coronary artery (LAD correspond to anterior wall, LCX correspond to lateral wall, RCA correspond to inferior wall). 3. Clinical symptom related target vessel revascularization including PCI or coronary artery bypass grafting.
次要结局
- Patient related adverse events(12-month)
研究者
Zhang Qi, MD
Chief doctor
Shanghai Jiao Tong University School of Medicine