Validation of OCT-based FUnctional diagnoSIs of corONary Stenosis (FUSION)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 28
- 主要终点
- Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)
研究概览
简要总结
The purpose of the FUSION study is to validate the diagnostic performance of Virtual Flow Reserve (VFR) by comparing it against a reference standard, fractional flow reserve (FFR).
详细描述
This study is a single-arm, prospective, multi-center study collecting OCT pullback images of lesions pre-percutaneous coronary intervention (PCI) and (optional) post-PCI procedure, and the corresponding pressure tracings and physiology indices. Up to 30 centers in the US will enroll approximately 310 patients. The expected duration of enrollment is approximately 15 months. The total duration of the clinical investigation is expected to be approximately 27 months.
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
- •Age ≥18 years
- •Patient provides written informed consent
- •Scheduled for clinically indicated coronary catheterization with the intent to perform physiologic assessment to guide physician clinical course (in lesions with visual % diameter stenosis 40-90%), if clinically indicated
- •Subject is undergoing invasive FFR with Adenosine (high-dose intra-coronary (IC) [200 μg for the left and or 100 μg for the right coronary artery] or 140 μg/kg/min for intravenous (IV)) used as hyperemic stimulus
- •Clinical presentation with or history of stable angina, unstable angina, or silent ischemia (defined as abnormal stress test or abnormal invasive physiology assessment) that has led to the procedure
排除标准
- •Prior history of myocardial infarction (MI) in the target vessel
- •Presence of acute ST Elevation Myocardial Infarction (STEMI)
- •Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI)
- •TIMI flow < Grade 3 at baseline or visible thrombus
- •Prior history of coronary artery bypass grafting (CABG)
- •Prior heart transplant
- •Severe valvular heart disease or history of valve repair or replacement
- •Prior history of PCI with stent in target vessel, or target vessel involves in-stent restenosis.
- •Target coronary vessel is supplied by major collaterals or is supplying major collaterals to a CTO (chronic total occlusion)
- •CTO in the target vessel
- •Severe diffuse disease observed in target vessel defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree
- •Presence of myocardial bridge (MB), regardless of vessel location
- •Contraindication for FFR examination or administration of vasodilators
- •Known LVEF ≤45%
- •Target lesion involves Left Main coronary artery or ostial right coronary artery
- •Known renal insufficiency (eGFR < 30 ml/kg/m^2 or serum creatinine ≥ 2.5 mg/dL) unless patient is on dialysis
- •Heart Failure NYHA Class III or IV
- •Subject is pregnant (For a female subject of childbearing potential, a pregnancy test must be performed within 14 days (≤14 days) prior to the index procedure per site standard test)
- •Subject has or had active COVID-19 symptoms and/or a positive test result within the prior 2 months
- •Participation in another clinical study of an investigational drug or device
- •Presence of aneurysm in the target vessel
- •Imaging and Pressure Tracing Exclusion Criteria:
- •Artifact in pre-PCI OCT for the target lesion or in the event of multiple target lesions, artifact in pre-PCI OCT for ALL target lesions
- •Target lesion requires any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement, or in case of multiple target lesions, ALL target lesions require-any preparation (including but not limited to balloon dilatation, atherectomy, etc.) prior to pre-PCI OCT and physiology measurement
- •Severe vessel tortuosity or calcification in the target vessel such that it is unlikely that the OCT catheter can be delivered
- •Target lesion not imaged by OCT or in the event of multiple target lesions, ALL target lesions not imaged by OCT
- •Pressure drift of > 0.03; i.e. Pd and Pa ratio value < 0.97 or > 1.03, unless physiology measurements are repeated after re-equalization
- •Target lesion or significant CAD beyond 60mm from coronary ostium; i.e. not able to clearly image and capture all disease segment with OCT in 1 run
- •Incorrectly done or unsuccessful catheter purge and/or contrast flush
- •Presence of plaque rupture and/or intravascular hematoma in target vessel (visual % diameter stenosis ≥ 40%)
- •Inability to receive intracoronary nitroglycerin prior to OCT or FFR
- •Use of flush media other than radiographic contrast
结局指标
主要结局
Sensitivity and Specificity of Virtual Flow Reserve (VFR) Against Fractional Flow Reserve (FFR)
时间窗: Baseline (pre-procedure) and immediately post-procedure
Sensitivity and specificity of the VFR compared with FFR each of which will be tested against a prespecified performance goal. FFR with a binary cut-off of 0.80 will be used as the reference standard for comparison. FFR or VFR value ≤ 0.80 will be considered positive (ischemia-causing), and FFR or VFR value \> 0.80 will be considered negative (non-ischemia-causing). Sensitivity is defined as the percentage of VFR positive lesions, in the group of FFR positive lesions. Sensitivity=TP/(TP+FN) x 100%, where TP denotes the number of True Positives (both VFR and FFR positive) and FN denotes the number of False Negatives (VFR negative but FFR positive). Specificity is defined as the percentage of VFR negative lesions in the group of FFR negative lesions. Specificity=TN/(TN+FP) x 100%, where TN denotes the number of True Negatives (both VFR and FFR negatives) and FP denotes the number of False Positives (VFR positive but FFR negative).
次要结局
- Overall Diagnostic Accuracy(Baseline (pre-procedure) and immediately post-procedure)
- Positive Predictive Value (PPV) and Negative Predictive Value (NPV)(Baseline (pre-procedure) and immediately post-procedure)
- Correlation Between VFR and FFR(Baseline (pre-procedure) and immediately post-procedure (post-procedure))
- Area Under Curve (AUC) Against FFR(Baseline (pre-procedure) and immediately post-procedure (post-procedure))