A HYbrid APproach Evaluating A DRug-Coated Balloon in Combination With A New Generation Drug-Eluting Stent in the Treatment of De Novo Diffuse Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 106
- 试验地点
- 6
- 主要终点
- DOCE at 12 Months
研究概览
简要总结
A Pilot Observational Study to evaluate safety and efficacy of the hybrid approach DES/DCB in treating de-novo diffuse lesions
详细描述
This is a prospective, non-randomized, single-arm, multi-center, pilot, noninterventional study whose aim is 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 encountered in daily clinical practice. 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 —（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 CAD involving segments suitable for a hybrid approach;
- •Signed Patient Informed Consent/Data Release Form
排除标准
- •Age <18 years;
- •Cardiogenic shock;
- •Pregnancy or breastfeeding;
- •Infarct-artery max diameter (within planned device deployment segment) <2.0 or >5.0 mm;
- •Comorbidities with life expectancy <6 months;
- •Severe calcification or/tortuosity proximally or at the DCB target segment;
结局指标
主要结局
DOCE at 12 Months
时间窗: 12 Months
A device oriented composite end-point (DOCE) of cardiac death, target vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) in the DES- and/or the DCB-treated segment within 12 months after the index procedure
次要结局
- Peri-procedural myocardial infarction(Pre-discharge)
- DOCE(Pre-discharge, 30 days, 6 months, 12 months)
- Thrombosis(12 months)
- Procedural Success(At procedure)
- Flow-limiting dissection(12 months)
研究者
ALFONSO IELASI
Principal Investigator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio