NCT06074549招募中不适用
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System (Bio-RESTORE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 17
- 主要终点
- Device Oriented Clinical Endpoint
研究概览
简要总结
The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.
详细描述
This registry will obtain additional safety, effectiveness, and performance data on the DynamX Coronary Bioadaptor System in the treatment of patients with ischemic heart disease due to de novo native coronary artery lesions in a real-world patient population.
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
- •Over 18 years of age
- •Patient understands the trial requirements and treatment procedures and provides informed consent
- •Patient indicated for PCI with stent implantation and receive at least one DynamX Bioadaptor implant in accordance with the product's Instructions for Use (IFU).
排除标准
- •Target Lesion(s) in the left main artery
- •Prior venous or arterial bypass grafts
- •In-stent restenosis
- •Patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (e.g., anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint
- •Patient is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the registry for any reason
结局指标
主要结局
Device Oriented Clinical Endpoint
时间窗: 12 Months
Composite of Target Lesion Failure (TLF): cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2
次要结局
- Rate of all MI(30 days and 12 months)
- Clinical Procedural Success(In-Hospital, assessed up to 7 days after procedure)
- Device Oriented Clinical Endpoint(30 days)
- Rate of target vessel failure (TVF)(30 days and 12 months)
- Rate of all revascularization(30 days and 12 months)
- Rate of all-cause death(30 days and 12 months)
- Clinical Device Success(In-Hospital, assessed up to 7 days after procedure)
- Patient Oriented Clinical Endpoint(30 days and 12 months)
- Composite of cardiovascular death, any myocardial infarction, and any revascularization(30 days and 12 months)
- Rate of stroke(30 days and 12 months)
- Rate of probable or definite stent thrombosis(30 days and 12 months)
- Duration of DAPT(30 days and 12 months)
研究者
研究点 (17)
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