Prospective, Multicenter and Observational Registry for the Evaluation of the Safety and Efficacy of Titanium-nitric Oxide-coated Stent (Optimax®) in Patients With Lesions With a Low Risk of Restenosis (Diameter ≥ 3.0 mm and Length ≤ 20 mm) (Reto 320 Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 5
- 主要终点
- Safety. The number of composite events of cardiac.
研究概览
简要总结
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent.
详细描述
This prospective registry is intended to evaluate the safety and efficacy of the Optimax® stent in de novo coronary lesions with reference diameter ≥ 3.0 mm and Length ≤ 20 mm.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age ≥ 18 years old.
- •Patients with de novo coronary lesion treated with Optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm.
- •Informed consent signed.
排除标准
- •Refusal of the patient to participate at the study.
- •Treatment of other injuries that do not meet the conditions (3x20).
结局指标
主要结局
Safety. The number of composite events of cardiac.
时间窗: 6 and 12 month
The number of composite events of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).
Efficacy: Incidence of clinically driven target lesion revascularization (TLR).
时间窗: 6 and 12 month
Incidence of clinically driven target lesion revascularization (TLR).Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
次要结局
- All death.(6 and 12 month)
- Cardiac death.(6 and 12 month)
- Target Vessel revascularization.(6 and 12 month)
- Target lesion revascularization.(6 and 12 month)
- Stent thrombosis (ARC definite/probable).(6 and 12 month)
- Major bleeding event (BARC type 2-5).(6 and 12 month)
- Stroke.(6 and 12 month)