Randomized Clinical Trial to Compare the Efficacy of Angiolite Stent Versus a Second-generation Drug-eluting Stent Such as Xience in Patients With Indication of Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 22
- 主要终点
- Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR))
研究概览
简要总结
Clinical trial with an "European Community marked" medical device in patients with ischemic heart disease and clinical indication of coronary revascularization with drug-eluting stent.
Clinical follow-up will be done according to this way: first month telephone or face-to-face interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography)
A randomized clinical trial to compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.(non-inferiority design)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 clinical or subclinical ischemic heart disease with indication of percutaneous revascularization.
- •"De Novo" lesions ≥ 70%
- •Reference diameters ≥ 2 mm and ≤ 4 mm Accepted participation in the registration with the signing of informed consent
排除标准
- •Cardiogenic shock
- •Pregnancy
- •Intolerance or allergy to anti platelet or anticoagulant therapy
- •Elective surgical procedure scheduled within 6 months after inclusion in the study
- •Expectancy of life of less than 1 year.
- •Impossibility of doing 1 year clinical follow-up.
- •Primary angioplasty in patients with killip class III-IV or mechanical complications.
- •Patient with pre-procedure restenosis.
- •Patients who will not be treated all lesions with the Angiolite stent.
- •Total occlusions
- •Truncus disease
研究组 & 干预措施
ANGIOLITE
Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.
干预措施: Angiolite (Device)
Xience
Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.
干预措施: Xience (Device)
结局指标
主要结局
Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR))
时间窗: 1 year
Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR)) during follow-up for no differences between Angiolite and Xience stents
Efficacy:Measure the late loss (LL) in the follow-up of the Angiolite stent is not different from the late loss of the xience stent (non-inferiority)
时间窗: 6 months
Measure the late loss (LL) in the follow-up of the Angiolite stent is not different from the late loss of the xience stent (non-inferiority)
次要结局
- Thrombosis rate(1 year)
- Follow up(1 year)
- MACE (Major Adverse Cardiac Events)(1 year)