Prospective, Multi-center, Double Blind, Randomised Study to Test the Safety of Deferral of Stenting in Physiological Non-significant Lesions in a Clinical Population of Intermediate Stenoses Using iFR and FFR
试验速览
- 阶段
- 不适用
- 入组人数
- 2,500
- 试验地点
- 51
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
Narrowing of coronary arteries interferes with blood flow and can cause chest pain. But patients may have more than one narrowing and studies have shown that not all narrowings need to be treated. To identify the narrowings that need treating cardiologists sometimes quantify the extent of the narrowing by measuring fractional flow reserve (FFR, the ratio of the pressure in the aorta to the pressure downstream of the narrowing).This technique requires the administration of drugs that add cost and time to the procedure and in some countries are simply unavailable. As a result despite the clear health and healthcare costs benefits of FFR its use is limited to less than 5% of procedure. We have developed a new technique called the instantaneous wave-free ratio (iFR) that does not require the administration of drugs for its accurate assessment. It has been approved for use in this indication. This study aims to compare clinical outcomes of patients whose treatment has been guided by iFR to those whose treatment has been guided by FFR. If iFR is found to provide the same clinical outcomes as FFR its adoption will permit the clear benefits of this approach of identifying the coronary narrowings that really need treatment to be applicable to a much larger patient population and further improve healthcare costs.
详细描述
Design:
Patients with one or more coronary stenoses, in which the physiological severity from coronary angiography is in question, will be randomised 1:1 to use of the instantaneous wave free ratio (iFR) or fractional flow reserve (FFR) to guide the treatment strategy for percutaneous coronary intervention (PCI).
Aims:
To assess whether the iFR is non-inferior to FFR when used to guide treatment of coronary stenosis with PCI.
Outcome measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years of age
- •Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- •Eligible for coronary angiography and/or percutaneous coronary intervention
- •Coronary artery disease with at least 1 or more native major epicardial vessels or their branches by coronary angiogram with visually assessed de novo coronary stenosis in which the physiological severity of the lesion is in question (typically 40-70% diameter stenosis).
- •Stable angina or acute coronary syndrome (non-culprit vessels only and outside of primary intervention during acute STEMI)
- •Exclusion criteria:
- •Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
- •Significant left main stenosis (>50% narrowing)
- •Tandem stenoses separated by more than 10 mm that require separate pressure guide wire interrogation or percutaneous coronary intervention (PCI) (not to be interrogated or treated as a single stenosis)
- •Total coronary occlusions (CTOs). NOTE: Patients with CTOs can be included if i) treatment of the CTO is completed first, ii) the CTO PCI is successful, iii) the CTO PCI is successful and iii) the physiological lesion is in another vessel
- •Restenotic lesions
- •Hemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg), balloon pump
- •Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
- •Contraindications to PCI (percutaneous coronary intervention) or drug-eluting stent (DES) implantation
- •Heavily calcified or tortuous vessels
- •Significant hepatic or lung disease (chronic pulmonary obstructive disease), and/or malignant disease with unfavourable prognosis that may influence survival within the next 5 years
- •STEMI (ST elevation myocardial infarction) within 48 hours of procedure
- •Severe valvular heart disease
- •ACS patients in whom more than one target vessel is present
排除标准
- 未提供
研究组 & 干预措施
iFR
Treatment guided by iFR
干预措施: iFR (Device)
FFR
Treatment guided by FFR
干预措施: FFR (Device)
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 30 days, 1, 2 and 5 years
Composite of death, myocardial infarction, unplanned revascularisation
次要结局
- Cost associated to iFR or FFR measurement(30 days, 1, 2 and 5 years)
- Death (all cause)(30 days, 1, 2 and 5 years)
- Death (cardiovascular)(30 days, 1, 2 and 5 years)
- Myocardial Infarction(30 days, 1, 2 and 5 years)
- Cost savings of removing secondary investigations(30 days, 1, 2 and 5 years)
- Repeat revascularisation(30 days, 1, 2 and 5 years)
- Quality of life assessed by EQ-5D-5L and Seattle Angina Questionnaire(30 days, 1, 2 and 5 years)