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临床试验/NCT04397211
NCT04397211进行中（未招募）不适用

Comparison of Angiography-derived Fractional FLow Reserve- And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients With CoRonary Artery Disease

Second Affiliated Hospital, School of Medicine, Zhejiang University23 个研究点 分布在 2 个国家目标入组 1,872 人开始时间: 2020年5月29日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
1,872
试验地点
23
主要终点
Patient-oriented composite outcome
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Comparison of Angiography-derived Fractional FLow Reserve And IntraVascular Ultrasound-guided Intervention Strategy for Clinical OUtcomes in Patients with CoRonary Artery Disease

详细描述

  1. The primary hypothesis is that angiography-derived FFR-guided strategy for PCI with a drug-eluting stent (DES) will show non-inferiority in rates of patients-oriented composite outcomes (POCO) at 12 months after randomization, compared with IVUS-guided strategy for PCI with a DES in patients with coronary artery disease.
  2. Study population and sample size calculation： Sample size calculation based on the event rates of previous trials, investigators predicted the rates of POCO at 12 months after PCI will be 7% in the Angiography-derived FFR-guided arm, and 8% in the IVUS-guided arm
  • Primary endpoint: patient-oriented composite outcome (a composite of all-cause death, MI, any revascularization) at 12 months after PCI
  • Design: non-inferiority, delta = 2.5%
  • Sampling ratio: angiography-derived FFR-guided strategy: IVUS-guided strategy = 1:1
  • Type I error (α): One-sided 2.5%
  • Accrual time: 3 years
  • Total time: 4 years (accrual 3 years + follow-up 1 years)
  • Assumption: POCO 7.0% vs. 8.0% in angiography-derived FFR or IVUS-guided strategy, respectively
  • Statistical power (1- β): 80%
  • Primary statistical method: Kaplan-Meier survival analysis with log-rank test
  • Estimated attrition rate: total 5%
  • Stratification in Randomization: Presence of diabetes mellitus (35% of patients in each group) Based on the above assumption, we would need total 1,872 patients (936 patients in each group) with consideration of an attrition rate.
  1. Research Materials and Indication for Revascularization： For the angiography-derived FFR-guided strategy arm, criteria for revascularization: angiography-derived FFR ≤ 0.80. For the IVUS-guided strategy arm, the criterion for revascularization is MLA ≤ 3mm2 or [3mm2 < MLA ≤ 4mm2 and plaque burden > 70%].

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
None

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

  • •① Subject must be ≥ 18 years. ② Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. ③ Patients suspected with ischemic heart disease. ④ Patients with ≥ 50% stenosis by angiography-based visual estimation eligible for stent implantation. ⑤ Target vessel size ≥ 2.5mm in visual estimation. ⑥ Target vessels are limited to major epicardial coronary arteries (left anterior descending artery[LAD], left circumflex artery [LCX], right coronary artery [RCA])

排除标准

  • •① The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled.) ② Patients with active pathologic bleeding. ③ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ④ History of bleeding. diathesis, known coagulopathy (including heparin-induced thrombocytopenia). ⑤Non-cardiac co-morbid conditions with life expectancy < 1 year. ⑥ Target vessel total occlusion. ⑦ Target lesion located in coronary arterial bypass graft. ⑧ Left main coronary artery stenosis ≥ 50%. ⑨ Not eligible for angiography-derived FFR (ostial RCA ≥ 50% stenosis, myocardial bridging, severe tortuosity, severe overlap, poor image quality)

结局指标

主要结局

Patient-oriented composite outcome

时间窗: 12 months

Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or any revascularization at 12 months after randomization according to the ARC definitions.

次要结局

  • Any non-target vessel/lesion revascularization(12, 24 and 60 months)
  • Cost-effectiveness analysis(12, 24 and 60 months)
  • Any nonfatal MI with peri-procedural MI(12, 24 and 60 months)
  • Stent thrombosis (definite/probable/possible)(12, 24 and 60 months)
  • Stroke (ischemic and hemorrhagic)(12, 24 and 60 months)
  • Acute success of procedure and rate of PCI optimization(At discharge (1 week after index procedure))
  • Patient-oriented composite outcome (POCO)(24, 60 months)
  • Target vessel failure(12, 24 and 60 months)
  • All-cause and cardiac death(12, 24 and 60 months)
  • Any nonfatal MI without peri-procedural MI(12, 24 and 60 months)
  • Any target vessel/lesion revascularization(12, 24 and 60 months)
  • Any revascularization (ischemia-driven or all)(12, 24 and 60 months)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (23)

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