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临床试验/NCT03027830
NCT03027830已完成不适用

Physiological and Clinical Assessment of the Provisional Side-branch Intervention Strategy for Coronary Bifurcation Lesions Using iFR Pressure Wires

Nova-Med Medical Research Association0 个研究点目标入组 50 人开始时间: 2014年3月1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
50
主要终点
Physiological evaluation of iFR-guided intervention

研究概览

简要总结

Even in the era of drug-eluting stents, bifurcation lesions remain one of the most challenging lesion subsets in coronary intervention practice. This study was performed to evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch intervention strategy.

详细描述

Fractional flow reserve (FFR) measurements require minimal and constant microvascular resistance which is routinely achieved by intravenous adenosine infusion. Adenosine-induced hyperemia establishes an optimal vascular environment for FFR measurement. However, breathlessness and chest tightness are common adverse events during adenosine infusion and severe asthma occurs occasionally. The Introduction of an adenosine-independent index (instantaneous wave-free ratio [iFR]) into clinical practice offered easier and hyperemia-free method for lesion assessment.

Physiological changes and clinical evaluation of iFR warrants further research. Therefore, the investigators conducted this study to evaluate the functional aspects of iFR-guided provisional jailed side-branch intervention strategy and compare clinical endpoints to conventional non-iFR-guided operations.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with acute coronary syndrome
  • Jailed side-branch of a vessel size > 2 mm
  • Vessel length > 40 mm
  • Lesion length < 10 mm by visual estimation

排除标准

  • Significant stenosis in the left main coronary artery or the main branch proximal to the stented segment
  • Totally occluded bifurcation lesions
  • Primary myocardial disease
  • Serum creatinine level of ≥ 2.

结局指标

主要结局

Physiological evaluation of iFR-guided intervention

时间窗: 6-month

iFR changes after drug-eluting balloon (DEB) inflation of the jailed side branch.

次要结局

  • Procedure time(30-day)
  • Fluoroscopy time(30-day)
  • Post-PCI angina(6-month)
  • 6-month heart failure class(6-month)
  • length of hospital stay(6-month)
  • In-hospital heart failure class(30-day)
  • Ejection fraction at 6 months' post operation(6-month)
  • The amount of dye injection for angiography(30-day)

研究者

发起方
Nova-Med Medical Research Association
申办方类型
Other
责任方
Sponsor

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