A Hybrid Approach Evaluating A Drug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of Long Diffuse Coronary Artery Disease: The HYPER II Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- TLF in DES/DCB treated segment at 12 months
研究概览
简要总结
An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease
详细描述
This is a prospective, non-randomized, single-arm, multi-center study aiming to assess the feasibility and the clinical outcomes of using the Restore DCB (Cardionovum GmbH, Bonn, Germany) in combination ("hybrid approach") with a new generation DES (type at operator's discretion) for the treatment of diffuse CAD (Coronary Artery Disease) encountered in daily clinical practice (lesion length > 38 mm). The rationale of the proposed strategy derives from the characteristics of DCB in treating the atherosclerotic disease without leaving a permanent structure in the vessel especially in case of diffuse CAD -avoiding a long metallic, permanent cage within extended coronary segments
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with stable or unstable CAD eligible for PCI (according to the international guidelines) because of diffuse long (>38 mm) CAD involving contiguous segments of the same vessel suitable for a hybrid approach (RVD>2.75 mm in the proximal DES target segment and RVD ≤2.75 mm ≥ 2.0 mm for the distal DCB target segment);
- •Signed Patient Informed Consent/Data Release Form
排除标准
- •Age <18 years;
- •Cardiogenic shock;
- •Pregnancy or breastfeeding;
- •Target vessel reference diameter (within planned device deployment segments) <2.0 or >5.0 mm;
- •Comorbidities with life expectancy <12 months
- •Severe calcification or/tortuosity proximally or at the DCB target segment;
- •Prior PCI and stent implantation in the target vessel.
结局指标
主要结局
TLF in DES/DCB treated segment at 12 months
时间窗: 12 months
Target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the drug-coated balloon (DCB)-treated segment within 12 months after the index procedure
次要结局
- Peri-procedural myocardial infarction(Pre-discharge)
- TLF(Pre-discharge, 30 days, 12 months, 24 months)
- Thrombosis(In-hospital (within 7 days after PCI), at 30-days, 12 months, 24 months follow-up)
- Flow-limiting dissection(At procedure)
- Procedural success(At procedure)