Randomized Clinical Trial Comparing A Titanium-Nitride-Oxide Coated Stent With A Zotarolimus-Eluting Stent in Patients With Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- In-stent late luminal loss
研究概览
简要总结
A Randomized Comparison of a Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) With a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) for Percutaneous Coronary Intervention
详细描述
Objectives: The purpose of this study is to compare the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) with a Zotarolimus-Eluting Stent (EndeavorTm, Medtronic) in a non-inferiority trial.
Design: Prospective, multi-center, randomized, non-inferiority trial to be conducted at 3 Swiss interventional cardiology centers. Patients will be randomized in a single-blind fashion (1:1 randomization) to either the Titanium-Nitride-Oxide Coated Stent (Helistent Titan2, Hexacath) or the Zotarolimus-Eluting Stent (EndeavorTm, Medtronic).
Study Population: Patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction, who qualify for percutaneous coronary interventions
Antiplatelet Therapy: Aspirin 100 mg qd indefinitely; Clopidogrel 75 mg qd for 3 months
Enrollment: A total of 300 patients will be enrolled
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •The following patients are eligible for inclusion
- •Age ≥18 years
- •Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, unstable angina, and non-ST elevation myocardial infarction
- •Presence of one or more coronary artery stenoses >50% in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents;
- •No limitation on the number of treated lesions, and vessels, and lesion length
排除标准
- •Known intolerance to aspirin, clopidogrel, heparin, stainless steel, titan, zotarolimus or contrast material
- •Inability to provide informed consent
- •Currently participating in another trial before reaching first endpoint
- •ST segment elevation myocardial infarction (STEMI)
研究组 & 干预措施
Titanium Nitride Oxide Coated Stent
Stent
干预措施: Helistent Titan2 (Titanium coated stent) (Device)
Zotarohlimus Eluting Stent
Stent
干预措施: EndeavorTM (Zotarolimus-Eluting Stent) (Device)
结局指标
主要结局
In-stent late luminal loss
时间窗: 6-8 months after stent implantation
次要结局
- TLR, TVR, Death or MI, CV death or MI, CV death, Death, MI, Stent thrombosis, Stenosis, Restenosis(30 days, 6-8 months, 1, 2, 3, 4 and 5 years)