Prospective Evaluation of a Virtual Non-invasive Percutaneous Intervention Planner in Patients With Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.
研究概览
简要总结
The PRECISE PERCUTANEOUS CORONARY INTERVENTION (PCI) PLAN STUDY is an investigator-initiated, international and multicenter study of patients with an indication for PCI aiming at assessing the agreement and accuracy of the HeartFlow Planner with invasive fractional flow reserve (FFR) as a reference.
详细描述
Multicenter study, including 120 patients at 5 centers in Europe and Asia. After identifying the presence of significant coronary stenosis by means of coronary angiography and invasive fractional flow reserve (FFR≤0.80) the patients will undergo the following procedures: Invasive FFR with intravenous adenosine (i.e. pre- and post-PCI). Optical coherence tomography-guided PCI (i.e. pre- and post-procedural imaging). PCI with newer generation drug-eluting stent.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery disease in a major epicardial vessel with an invasive fractional flow reserve (FFR) ≤0.80
- •An indication to Percutaneous coronary intervention
排除标准
- •Angiographic exclusion criteria
- •Severely calcified lesion/vessel
- •Bifurcation lesions.
- •Ostial lesions.
- •Left main disease.
- •Severe vessel tortuosity.
- •Clinical exclusion criteria
- •Chronic obstructive pulmonary disease
- •Contraindication to adenosine
- •NYHA class III or IV, or last known left ventricular ejection fraction <30%
- •Uncontrolled or recurrent ventricular tachycardia
- •Atrial fibrillation, flutter or arrhythmia
- •History of recent stroke (≤90 days)
- •History of acute coronary syndrome (≤90 days)
- •Prior myocardial infarction
- •History of ischemic stroke (>90 days) with modified RANKIN score ≥ 2
- •History of any hemorrhagic stroke
- •Previous revascularization (PCI or Coronary artery bypass grafting)
- •Active liver disease or hepatic dysfunction, defined as AST or ALT > 3 times the ULN
- •Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2
- •Body mass index>35 kg/m2
- •Nitrate intolerance
- •Contra-indication to heart rate lowering drugs
- •Imaging-related
- •Insufficient coronary CT Angiography image quality.
结局指标
主要结局
Agreement on post-PCI fractional flow reserve between virtual treatment based on FFRct planner and measured invasive post-PCI fractional flow reserve.
时间窗: The primary endpoint will be assessed immediately after the procedure (PCI).
The agreement will be assessed by Bland Altman method
次要结局
未报告次要终点
研究者
Jeroen Sonck
Co-Director Cardiovascular Center OLV-Aalst
Onze Lieve Vrouw Hospital