A U.S. Post-Approval Study of the SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System Evaluating the SYNERGY XLV (MEGATRON) Stent System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Target Lesion Failure (TLF) rate
研究概览
简要总结
This is a post-market, standard of care, real-world observational study to assess the clinical outcomes of the SYNERGY XLV (MEGATRON) Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 28 mm in length (by visual estimate) in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter (by visual estimate). This Post Approval study is a cohort associated with the Evolve 4.5/5.0 (SYNERGY LV) Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT03875651.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires treatment with a SYNERGY XLV (Megatron) stent
排除标准
- •Planned treatment with a non-SYNERGY stent
结局指标
主要结局
Target Lesion Failure (TLF) rate
时间窗: 12 Months
12-month Target Lesion Failure (TLF) rate, defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
次要结局
- Clinical endpoints(At Hospital Discharge (typically 1-2 days post index procedure), and at 6 months, 12 months, 2 years)
- Periprocedural endpoints(At Hospital Discharge (typically 1-2 days post index procedure))