NCT04138238已完成不适用
Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Sirolimus-eluting Coronary Stent System in the Treatment of All-comer Patients With Coronary Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 26
- 主要终点
- Device Oriented Composite Endpoint (DOCE)
研究概览
简要总结
This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex arm of the TALENT trial) and demonstrate that the Supraflex Cruz stent is not inferior to the BioFreedom stent in High Bleeding Risk (HBR) patients (400 patients) with respect to device oriented composite endpoint (DOCE) at 12 months. All patients will be followed up to 12 months after the index procedure.
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
- •Patients ≥ 18 years old
- •De novo or re-stenotic significant stenosis in at least one native coronary artery
- •Patients with silent ischemia, stable angina, unstable angina or non-STEMI eligible for PCI (no limitation of the number of treated lesions and vessels, except higher tercile of Syntax score assessed by the site)
- •Target lesions suitable for PCI with Drug-eluting Stent (DES) diameter between 2.00 and 4.50 mm
- •Total lesion length should be from 15 to 120 mm
- •Patient is willing and capable to sign the written informed consent and comply with all requirements of the registry
- •Planned staged procedures are allowed within 3 months using Supraflex Cruz stent only
排除标准
- •SYNTAX Score > 32
- •Hemodynamic instability or cardiogenic shock
- •Known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (DAPT) medication required by current practice
- •Subject is pregnant, nursing or is a woman with child-bearing potential
- •Any co-morbid condition with life expectancy < 1 year or that may result in protocol non-compliance
- •Patients who are participating in another drug or device investigational study, which has not reached its primary endpoint
- •Patients under judicial protection, tutorship or curatorship
结局指标
主要结局
Device Oriented Composite Endpoint (DOCE)
时间窗: 12 months
DOCE is a composite of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically-driven target lesion revascularization (TLR)
次要结局
- All death, cardiovascular death and non-cardiovascular death(6 months and 12 months)
- Target vessel MI and MI not clearly attributable to non-target vessel(6 months and 12 months)
- All myocardial infarction (MI)(6 months and 12 months)
- All target lesion revascularization (TLR)(6 months and 12 months)
- All target vessel revascularization (TVR)(6 months and 12 months)
- Stent thrombosis (ARC2)(6 months and 12 months)
- Lesion success(Up to 1 Day)
- Procedure success(Up to 7 Days)
- Major bleeding (BARC 3 to 5) in the HBR population(6 months and 12 months)
- All revascularization(6 months and 12 months)
- Clinically indicated target lesion revascularization (TLR)(6 months and 12 months)
- Device success(Up to 1 Day)
研究者
研究点 (26)
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