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临床试验/NCT06577038
NCT06577038Enrolling By Invitation不适用

Prospective, International, Multicenter, All-comers Registry for the Study of Intravascular Lithotripsy in Coronary Interventions

Leiden University Medical Center8 个研究点 分布在 3 个国家目标入组 1,000 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,000
试验地点
8
主要终点
procedural success

研究概览

简要总结

multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology.

详细描述

The primary objectives are:

  1. To analyze the trends of IVL use overall and according to clinical/anatomical indications
  2. To evaluate the rates of procedural success, defined as success in facilitating stent delivery with <30% residual stenosis and without in-hospital
  3. To describe the cumulative hierarchical incidence of MACE defined as: cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure

The secondary objectives are:

  1. To describe the rate of MACE at 3-, 6- and 12-months following the index procedure
  2. To assess the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis at any time point, any type of angina at 30-days, 3-, 6- and 12-months following the index procedure
  3. To describe the rates of target lesion failure (TLF) (see end-points definitions section)
  4. To describe the rates of device crossing success (see end-points definitions section)
  5. To describe the rates of serious angiographic complications (see end-points definitions section)
  6. To assess predictors of clinical outcomes based on patient and procedural characteristics
  7. To analyze current standards of practice regarding IVL technology in a real-world multinational cohort (technique, training, local protocols).

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

入选标准

  • Age >18 years-old
  • Ability to provide written informed consent

排除标准

  • Patient has any comorbidity or condition that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent
  • Patient belongs to a vulnerable population Subject is a member of a vulnerable population , including individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

结局指标

主要结局

procedural success

时间窗: Periprocedurally and from hospital admission to discharge (an average of 2 days)

success in facilitating stent delivery with \<30% residual stenosis and without in-hospital MACE

cumulative hierarchical incidence of MACE

时间窗: At 30 days follow-up

cardiac death, non-fatal target vessel myocardial infarction (MI), or clinically driven target lesion revascularization (TLR) at 30-days following the index procedure

次要结局

  • rate of MACE at 6 months(At 6 months follow-up)
  • rate of MACE at 3 months(At 3 months follow-up)
  • rate of MACE at 12 months(At 12 months follow-up)
  • the rates of all causes mortality, clinically driven target lesion revascularization (TLR) or target vessel revascularization (TVR), any revascularization (non TLR, non TVR) and ARC-defined stent thrombosis(at 12-months follow-up)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

José M Montero Cabezas

Principal investigator

Leiden University Medical Center

研究点 (8)

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