Diagnostic Performance and Prognostic Ability of AccuFFRangio for Non-IRA in NSTE-ACS Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- Vessel-oriented composite endpoints (VOCEs)
研究概览
简要总结
This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The purpose of this study is to investigate the diagnostic performance and prognostic ability of AccuFFRangio for non-IRA in NSTE-ACS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 Years and older
- •Non-ST-segment elevation acute coronary syndrome patients with at least 1 non-IRA
- •Diameter stenosis of 50%-90% by visual estimate
- •Reference vessel size > 2 mm in stenotic segment by visual estimate
排除标准
- •LVEF ≤ 40%
- •eGFR < 60 mL/min
- •Allergy to contrast media, adenosine
- •Prior CABG
研究组 & 干预措施
AccuFFRangio Group
NSTE-ACS patients with multiple lesions who met the requirements of the study were enrolled and received coronary angiography. First, the revascularization of the criminal vessel (PCI) was completed. The patients were randomly grouped and divided into AccuFFRangio Group and Angiography Group if the treatment results were good. The AccuFFRangio Group was defined as non-IRA of these patients who were treated with PCI after angio-FFR measurement with FFR≤0.8.
干预措施: AccuFFRangio-guided strategy (Other)
Angiography Group
The Angiography Group was defined as PCI treatment for non-IRA when diameter stenosis > 70% based on angiographic results.
干预措施: Angiography-guided strategy (Other)
结局指标
主要结局
Vessel-oriented composite endpoints (VOCEs)
时间窗: 1 year
Composite of vessel-related cardiovascular death, vessel-related myocardial infarction, and ischemia-driven target vessel revascularization.
Post-PCI AccuFFRangio
时间窗: 1 year
AccuFFRangio limits to yield no VOCEs.
次要结局
- Cost analysis(1 year)