Impiego Del Pallone Medicato Per il Trattamento di Piccoli Vasi Coronarici in Confronto Con Stent Medicato - Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 主要终点
- Verify the non-inferiority of DCB
研究概览
简要总结
This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years.
- •Stable or unstable coronary artery disease.
- •Native coronary artery lesion in vessel with diameter <2.75 mm.
- •Clinical indication to percutaneous coronary intervention (PCI).
排除标准
- •Enrolment in another study with any investigational drug or device.
- •Acute or recent (≤48 hours) myocardial infarction.
- •Creatinine clearance <50 ml/min.
- •Left ventricle ejection fraction <30%.
- •Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure.
- •Heavily calcified and severely tortuous lesions.
结局指标
主要结局
Verify the non-inferiority of DCB
时间窗: up to 6 months
the primary objective of the study is the non-inferiority of the DCB compared to DES in terms of absence of restenosis, defined as reoccurrence of stenoses of at least 50% of the lumen of the vessel at angiographic follow-up (6 months after surgery).
次要结局
- Number of Participants with changes of vessels lumen(up to 12 months)
- Concentration in blood chemistry(up to 6 months)
- Number of Participants with adverse events(up to 12 months)
研究者
Bernardo Cortese
Principal Investigator, A.O. Fatebenefratelli Milano, Italy
Fatebenefratelli and Ophthalmic Hospital