Safety and Clinical Performance of the Yukon Choice PC, Yukon Chrome PC & Yukon Choice Flex Sirolimus Eluting Bioabsorbable Polymer Stents Systems in Routine Clinical Practice: e-Yukon Global Registry.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Target Lesion Failure
研究概览
简要总结
The goal of this observational study is to collect safety and performance information in the setting of a large-scale clinical registry.
Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.
The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.
详细描述
- Prospective, observational, noninterventional, multicenter, international clinical registry
- Allocation: consecutively treated patients, non-randomized
- Masking: None (open label)
- Observational model: Longitudinal
- Inclusion period: 2 years
- Follow-up period: at 1 year
- Study duration: 3 years
Patients meeting the selection criteria will be included, in chronological order of their implantation. This registry does not require any additional procedures, follow-up interventions, or ionizing radiation for patients.
The inclusion period is planned to last 2 years, starting in Q1 2023. The study will be complete when data on all patient's follow-up for one year have been collected.
List of visits:
V0: During hospitalization: consultation baseline, data of the intervention and data at discharge
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Any patient who was implanted only with a Yukon Choice PC, a Yukon Chrome PC or/and a Yukon Choice Flex stent within previous 2 days.
- •Patient ≥ 18 years old.
- •Male or non-pregnant female patient (Note: females of childbearing potential must have a negative pregnancy test prior to enrollment in the study).
排除标准
- •Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- •Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the trial.
- •Concurrent medical condition with a life expectancy of less than 12 months.
结局指标
主要结局
Target Lesion Failure
时间窗: 12 months
Defined as the composite of cardiac death, target-vessel myocardial infarction and clinically indicated target lesion revascularization
次要结局
- Clinically driven target lesion revascularization(12 months)
- Stent Thrombosis(12 months)
- Myocardial infarction(12 months)
- Target-vessel myocardial infarction(12 months)
- Device success(12 months)
- Procedure Success(12 months)
- All cause death(12 months)
- Cardiac death(12 months)
- Any revascularization(12 months)