DRKS00017160已完成4 期
Correlation of Machine Learning Computed Tomography-Based Fractional Flow Reserve (CT-FFRML) with Instantaneous Wave Free Ratio (iFR®) to Detect Hemodynamically Significant Coronary Stenosis - CT FFR
Volcano Europe BVBA/SPR0 个研究点目标入组 40 人开始时间: 2019年5月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Clinical indication for cCTA.
- •Indication for invasive assessment of coronary lesion depending on the result of
- •Stable coronary heart disease with coronary stenosis of unclear hemodynamic
排除标准
- •Significant valvular pathology
- •Hemodynamic instability at the time of intervention
- •High sensitive troponin I (>0,2 ng/ml)
- •Severe vessel tortuosity and/or severe calcification by angiogram
- •Time between cCTA and ICA procedures exceeding 1 month
- •Contraindications for a cCTA/ICA (e.g. allergy to contrast agents, renal failure)
- •Severely reduced left ventricular function
- •Patients with prior coronary artery bypass grafting (CABG)
- •Bifurcation stenosis types D to G (SYNTAX score classification)
- •Severe stenosis of the proximal left main and/or the proximal right coronary artery
- •Percutaneous coronary stent implantation in the vessel of interest
- •Inadequate image quality of the cCTA dataset
研究者
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