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临床试验/NCT07297641
NCT07297641招募中不适用

Intravascular Imaging-Guided Versus Angiography- Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2026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
入组人数
1,500
试验地点
1
主要终点
MACE

研究概览

简要总结

This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance.

详细描述

Through early revascularization, percutaneous coronary intervention (PCI) and following pharmacotherapy have improved clinical prognosis among patients with coronary artery disease. However, the presence of stent failure events remained posing long-term risk of adverse cardiac events. Although the utilization of drug-eluting stents (DES), the incidence of in-stent restenosis (ISR) continued to occur at an incidence rate of 1-2% annually. Also, the prognosis of ISR was worse than that in denovo lesions considering its complex mechanisms(stent under-expansion, neointimal hyperplasia or neo-atherosclerosis).Compared with coronary angiography, intravascular imaging(OCT/IVUS) provides detailed anatomical information regarding reference vessel dimensions and lesion characteristics, including severity of diameter stenosis, lesion length, and morphology. Identifying the mechanism of stent failure is paramount because the causative factors will influence the selection of treatment strategy, ultimately impacting the prognosis of the revascularization. However, clinical evidence for the exact benefit of intravascular imaging-guidance for ISR lesions is limited.

Therefore, this study aimed to compare the efficacy and safety of intravascular imaging -guided PCI in patients with ISR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Patients with DES-ISR lesions; (2) Life expectancy of at least 1 year; (3) DES-ISR lesions occurring for the first time in native coronary arteries and suitable for re-PCI based on angiographic findings.

排除标准

  • (1) Bare-metal stent in-stent restenosis (BMS-ISR). (2) Non-DES-ISR lesions. (3) Incomplete clinical and angiographic data. (4) Poor quality of IVUS or angiographic images. (5) Recurrent DES-ISR. (6) Optical coherence tomography (OCT) guidance.

结局指标

主要结局

MACE

时间窗: 3-year

Major adverse cardiovascular events following PCI

次要结局

  • Stent expansion(Intraprocedural)
  • MSA(Intraprocedural)

研究者

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

Ye-fei

chief physician

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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