跳至主要内容
临床试验/NCT03709836
NCT03709836已完成不适用

Computed Tomography Angiography Prediction Score for Side Branch Occlusion in Coronary Bifurcation Intervention (CT-PRECISION)

National Institute of Cardiology, Warsaw, Poland1 个研究点 分布在 1 个国家目标入组 363 人开始时间: 2018年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
363
试验地点
1
主要终点
SB occlusion

研究概览

简要总结

Lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (PCI). Revascularization within bifurcation sites remains technically challenging. While the most optimal interventional treatment strategy for bifurcation lesions is still debatable, side branch (SB) occlusion is one of the most serious procedural complications with prevalence rates over 7%.

Numerous mechanisms of the SB occlusion (e.g. plaque or carina shift, coronary artery dissection, thromboembolism, coronary artery spasm, etc) have been postulated. Regardless of the cause, loss of the SB is associated with increased risk of periprocedural mortality and myocardial infarction. Therefore, PCI involving coronary bifurcation mandates consideration of the risk of SB compromise. The CT-PRECISION (Computed Tomography angiography PREdiCtIon score for SIde branch Occlusion in coronary bifurcation interventioN) registry was designed to evaluate the application of coronary computed tomography angiography (coronary CTA) for the prediction of SB occlusion during percutaneous revascularization of bifurcation lesions. The main purpose of this single-center study is to develop a noninvasive CTA-based prediction tool to determine the procedural outcome of PCI in bifurcation lesions.

详细描述

Coronary CTA allows for precise and noninvasive evaluation of coronary bifurcation lesions. Pre-procedural planning for coronary revascularization using CTA provides detailed characterization of bifurcation anatomy and morphology including the spatial distribution of coronary plaque. To date there has been no compiled CTA-based prediction model for SB occlusion in coronary bifurcation intervention.

The CT-PRECISION registry is a retrospective observational cohort study of patients undergoing preprocedural coronary CTA before PCI involving coronary bifurcation lesions between January 2010 and July 2018. The study is designed to enroll 400 consecutive patients undergoing elective main vessel stenting with a provisional approach to the SB at a single high-volume PCI center.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred for attempted PCI of a bifurcation lesion with a significant SB as part of their standard of care
  • Initial stenting of the main branch with a provisional approach to the SB
  • Performance of dual-source coronary CTA within 30 days before attempted PCI

排除标准

  • Age <18 years

结局指标

主要结局

SB occlusion

时间窗: intraprocedural

SB occlusion defined as a any decrease in Thrombolysis in Myocardial Infarction (TIMI) flow grade or the absence of flow in the SB after main vessel stenting

次要结局

未报告次要终点

研究者

发起方
National Institute of Cardiology, Warsaw, Poland
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验