Ultrathin Drug Eluting Stents for Patients With Left-main, bifurcaTion, chRonic totAl Occlusion, or In-stent Restenosis Coronary Lesion in Real Life: the ULTRA a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of target lesion failure (TLF)
研究概览
简要总结
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years old
- •Unprotected left main stenosis
- •Bifurcation coronary stenosis (with side branch diameter ≥ 2.5 mm)
- •Chronic total coronary occlusion
- •In-stent restenosis
- •Treated with the following devices:
- •Supraflex Cruz
排除标准
- •patients died during the index revascularization procedure
结局指标
主要结局
Incidence of target lesion failure (TLF)
时间窗: Up to 2 years
A composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis
次要结局
- Incidence of acute myocardial infarction (AMI)(Up to 2 years)
- Incidence of definite stent thrombosis(Up to 2 years)
- Incidence of target lesion revascularization(Up to 2 years)
- Incidence of all-cause death(Up to 2 years)
- Incidence of cardiovascular death(Up to 2 years)
- Incidence of target Vessel Myocardial Infarction(Up to 2 years)
- Incidence of target vessel revascularization (TVR)(Up to 2 years)
- Incidence of major bleedings(Up to 2 years)
研究者
Fabrizio D'Ascenzo
Clinical Professor
A.O.U. Città della Salute e della Scienza
