跳至主要内容
临床试验/NCT03522038
NCT03522038Unknown不适用

Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)

Shanghai Zhongshan Hospital0 个研究点目标入组 300 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
主要终点
Change from Baseline FFR at 6 months after CTO PCI

研究概览

简要总结

The aim of this study is to investigate the role of functional evaluation for predicting clinical outcome in patients with coronary chronic total occlusion (CTO) undergoing percutaneous coronary intervention (PCI), and to evaluate the clinical evidence for the using of fractional flow reserve (FFR), coronary flow reserve (CFR), index of myocardial resistance (IMR) and dynamic single photon emission computed tomography (D-SPECT) in these patients.

详细描述

PCI for CTO has dramatically changed in recent years. Although, with the improvement of devices and refinement of operator techniques, PCI of CTO can currently be performed with high success and low complication rates at experienced centers, the clinical benefit of recanalization of CTO is still a matter of debate. Accumulating evidence suggests that the improvement of left ventricular functional and prognosis is closely related with the area of viable myocardium, which has the potential for contractile recovery after revascularization. For the majority of interventional cardiologists, coronary angiography is the only invasive test deemed necessary for clinical decision-making, despite its weak ability to predict the functional impact of vascular occlusion on the subtended myocardium. To overcome this limitation, adjunctive diagnostic tools for functional evaluation, such as FFR, CFR, IMR and D-SPECT, have been introduced. In non-CTO patients, physiology-guided revascularization strategy has been definitely proven to be better than angiography-guided strategy in pivotal landmark studies. However, the clinical value of these functional parameters for the PCI of CTO is still unknown.

The aim of this study was to determine whether functional evaluation is a better predictor of clinical outcome in patients with CTO undergoing PCI.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 and ≤80
  • Patients diagnosed with CTO by coronary angiography
  • Patient planned to receive PCI
  • Diameter of CTO vessel > 2.25 mm

排除标准

  • Age >80 or <18
  • Myocardial infarction with 1 months
  • Inability to give informed consent

结局指标

主要结局

Change from Baseline FFR at 6 months after CTO PCI

时间窗: At baseline and 6 months after CTO PCI

CFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel. CFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route. The CFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.

Change from Baseline Myocardial perfusion at 6 months after CTO PCI

时间窗: At baseline and 6 months after CTO PCI

The myocardial perfusion before and after CTO PCI was evaluated by dynamic SPECT.

Change from Baseline Myocardial Viability at 6 months after CTO PCI

时间窗: At baseline and 6 months after CTO PCI

The myocardial viability before and after CTO PCI was evaluated by PET-MRI.

次要结局

  • In-stent restenosis(6 months after CTO PCI)
  • MACE(6 months after CTO PCI)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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