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临床试验/NCT07231835
NCT07231835招募中不适用

RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年11月11日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
3,000
试验地点
1
主要终点
TLF at 1 year

研究概览

简要总结

The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.

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

  • Patients undergoing PCI with the Protégé paclitaxel-eluting DCB
  • Age ≥ 18 years
  • Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI
  • Reference vessel diameter between 2.0 - 4.5 mm
  • Patient suitable for dual antiplatelet therapy (DAPT)

排除标准

  • Inability to provide informed consent
  • Allergy to paclitaxel

结局指标

主要结局

TLF at 1 year

时间窗: From enrollment to 1 year follow-up

Target Lesion Failure (TLF) at 1 year, defined as a composite of: * Cardiovascular death * Target vessel myocardial infarction (TV-MI) * Clinically driven target lesion revascularization (TLR)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bimmer Claessen

md phd

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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