跳至主要内容
临床试验/NCT05205148
NCT05205148招募中不适用

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

A.O.U. Città della Salute e della Scienza1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年1月1日最近更新:
适应症

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

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

发起方
A.O.U. Città della Salute e della Scienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabrizio D'Ascenzo

Clinical Professor

A.O.U. Città della Salute e della Scienza

研究点 (1)

Loading locations...

相似试验