Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 5
- 主要终点
- Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR)
研究概览
简要总结
The purpose of this study is to compare FFR measurements done with adenosine to FFR measurements done with contrast, where the contrast is injected using the ACIST CVi automated contrast injector.
The ACCELERATION study will support a safer approach to FFR for patients by potentially reducing toxic drug exposure (adenosine). The 2 main objectives of the study are:
- Perform a methods comparison between cFFR and the reference standard aFFR, where cFFR is performed using an automated injector with a standardized volume and rate of delivery of contrast with known osmolality.
- Evaluate the association between final post-PCI FFR and long-term clinical outcomes. The long-term clinical outcomes will include TVR and composite MACE (death, MI, and TVR) at 30 days and 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Have the capacity to understand and sign an informed consent or have a legally authorized representative (LAR) that can understand and sign an informed consent prior to initial arteriotomy access
- •Age > 18 years of age at the time of signing the informed consent
- •Clinically stable and undergoing non-emergent cardiac catheterization for appropriate indications
- •Willing to be contacted by telephone at 30 days (if no standard of care visit) and at 1 year with chart review for events.
- •Target vessel with an intermediate lesion of 40-70% stenosis by angiographic assessment (a visual estimation by the operator). Serial lesions, diffuse disease, or ostial lesions ("all-comer" lesions) are acceptable if the operator would normally perform FFR and proceed with PCI (or other revascularization) if positive.
排除标准
- •Any condition associated with a life expectancy of less than 1 year
- •Participation in another clinical study using an investigational agent or device within the past 3 months
- •Ejection fraction ≤ 35%
- •Creatinine ≥ 2
- •Severe valvular heart disease
- •Decompensated acute diastolic or systolic heart failure
- •Bronchospastic chronic obstructive pulmonary disease or other intolerance to adenosine
- •ST-segment elevation myocardial infarction culprit lesion or lesions with any thrombus burden after diagnostic angiography
- •Lesions with severe calcification after diagnostic angiography
- •Lesions in a target vessel supplied by a patent graft
研究组 & 干预措施
aFFR vs cFFR
All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System
干预措施: Iopamidol (Drug)
aFFR vs cFFR
All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System
干预措施: adenosine (Drug)
aFFR vs cFFR
All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System
干预措施: Navvus® Catheter (Device)
aFFR vs cFFR
All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System
干预措施: CVi® Contrast Delivery System (Device)
结局指标
主要结局
Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR)
时间窗: Baseline
FFR is the ratio between the maximal myocardial flow measured in a diseased coronary artery and the theoretical maximal blood flow in the same territory in the absence of the stenosis, measured using adenosine induced hyperemia (aFFR) or contrast induced hyperemia (cFFR). Contrast FFR is being compared to the gold-standard adenosine FFR. An aFFR equal or less than 0.80 is the gold-standard cut-off to benefit from intervention. Reported as the percentage of agreement between aFFR and cFFR.
Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves
时间窗: Baseline
The qualitative method comparison assesses the agreement as to which lesion is flow limiting. The contrast FFR measurement that corresponds to adenosine FFR measurement value of 0.8 will be used as the cutoff value for determining whether a lesion is flow limiting for contrast FFR. Reported as the percentage of agreement between aFFR and cFFR.
次要结局
- Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR)(1 year post procedure)