Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI Optimization
概览
- 阶段
- 4 期
- 干预措施
- Pressure Microcatheter guided strategy - PIOS MC
- 疾病 / 适应症
- Coronary Artery Disease
- 发起方
- CoreAalst BV
- 入组人数
- 2500
- 试验地点
- 32
- 主要终点
- Compare the rate of MACE between pressure microcatheter and pressure wire strategies.
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
Recently, a new device for measuring physiological lesion severity, the pressure microcatheter, was introduced. The pressure microcatheter provides similar information to the conventional measurement technique but differs as it is easily advanced on a customary coronary wire and simplifies pullback maneuvers. The pressure microcatheter has been shown to provide comparable FFR results to pressure wires.
Insightful-FFR is an investigator-driven, multicenter, randomized, open-label and prospective trial of patients with stable coronary artery disease or stabilised non-ST elevation acute coronary syndrome (ACS) with epicardial stenosis considered for PCI aiming at comparing clinical outcomes between pressure microcatheter and pressure wire-guided strategies. The study hypothesis states that the use of a Pressure Microcatheter for clinical decision making would be non-inferior to pressure wire-based strategy
After determining the presence of a coronary artery disease/ stabilized acute coronary syndrome, patients will be randomized to use a pressure microcatheter (investigational device) or a pressure wire (comparator) to guide and optimize percutaneous coronary intervention (PCI). Patients will be followed up in hospital at 12 months and yearly until five years.
研究者
入排标准
入选标准
- •The subject must be at least 18 years of age and younger than 85 years old.
- •Eligible for elective PCI.
- •Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)
- •Subject willing to participate and able to understand, read and sign the Informed Consent.
排除标准
- •STEMI as clinical presentation.
- •Chronic total occlusion as a target vessel.
- •Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
- •Uncontrolled or recurrent ventricular tachycardia.
- •Hemodynamic instability.
- •Severe valvular disease.
- •Severe renal dysfunction defined as an eGFR ≤30 mL/min/1.73 m
- •Comorbidity with life expectancy ≤ 2 years.
- •Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least six months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care.
- •Planned major cardiac or non-cardiac surgery within 24 months after the index procedure. Note: major surgery is any invasive procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
研究组 & 干预措施
Pressure Microcatheter guided strategy - PIOS-MC
Patients will be treated with the Pressure Microcatheter during PCI. After completing an angiographically successful PCI, patients will be randomized to FFR-guided stent optimization (PIOS).
干预措施: Pressure Microcatheter guided strategy - PIOS MC
Pressure Wire guided strategy - PIOS-PW
Patients will be treated with the Pressure Wire during PCI. After completing an angiographically successful PCI, patients will be randomized to FFR-guided stent optimization (PIOS).
干预措施: Pressure Wire guided strategy - PIOS - PW
Pressure Microcatheter guided strategy - Standard of care
Patients will be treated with the Pressure Microcatheter during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.
干预措施: Pressure Microcatheter guided strategy - Standard of care
Pressure Wire guided strategy - Standard of care
Patients will be treated with the Pressure Wire during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.
干预措施: Pressure Wire guided strategy - Standard of care
结局指标
主要结局
Compare the rate of MACE between pressure microcatheter and pressure wire strategies.
时间窗: 12 Months follow-up
Compare the rate of major adverse cardiovascular events (MACE) defined as the combined rate of all cause death, myocardial infarction (MI), and unplanned revascularization between pressure microcatheter and pressure wire strategies at 12-months follow-up.
次要结局
- Compare the post-PCI FFR between the pressure microcatheter and pressure-wire guided strategies in patients undergoing PCI.(Periprocedural time frame)
- Compare in-hospital resource utilisation between PIOS-MC and PIOS-PW.(During the hospitalisation (from admission to the hospital until discharge after the procedure))
- Compare the post-PCI FFR between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.(Periprocedural time frame)
- Compare the rate of symptoms-free status between pressure microcatheter and pressure wire strategies.(12 Months follow-up)
- Compare the rate of target vessel failure (TVF) between PIOS and SOC.(12 Months follow-up)
- Compare in-hospital resource utilization between pressure microcatheter and pressure wire strategies.(During the hospitalisation (from admission to the hospital until discharge after the procedure))
- In patients undergoing PCI, compare the procedural time in minutes between pressure PIOS-MC and PIOS-PW strategies.(Periprocedural time frame)
- Compare the proportion of FFR > 0.90 between pressure microcatheter (MC) PIOS and SOC strategies in patients undergoing PCI.(Periprocedural time frame)
- Compare the proportion of FFR > 0.90 between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.(Periprocedural time frame)
- Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for post-PCI FFR.(Periprocedural time frame)
- Compare the rate of myocardial infarction between pressure microcatheter and pressure-wire guided strategies.(12 Months follow-up)
- Compare the procedure time between pressure microcatheter and pressure-wire guided strategies in minutes.(Periprocedural time frame)
- Compare the post-PCI FFR between pressure PIOS and SOC strategies in patients undergoing PCI.(Periprocedural time frame)
- In patients undergoing PCI, compare the rate of cardiac death between PIOS and SOC.(12 Months follow-up)
- Compare the proportion of FFR > 0.80 between pressure PIOS and SOC strategies in patients undergoing PCI.(Periprocedural time frame)
- Compare the proportion of FFR > 0.80 between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI(Periprocedural time frame)
- Compare the rate of unplanned revascularisation between pressure microcatheter and pressure-wire guided strategies.(12 Months follow-up)
- In patients undergoing PCI, compare the rate of target vessel myocardial infarction (MI) between PIOS and SOC.(12 Months follow-up)
- Compare the rate of all-cause death between pressure microcatheter and pressure-wire guided strategies.(12 Months follow-up)
- Compare the rate of PCI-related myocardial infarction (MI) (type 4a) between pressure PIOS and SOC.(During the procedure)
- Compare the rate of angiographic complications between pressure microcatheter and pressure-wire guided strategies.(Periprocedural time frame)
- In patients undergoing PCI, compare the rate of ischemia-driven target-vessel revascularization (ID-TVR) between PIOS and SOC.(12 Months follow-up)
- Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for target vessel failure (TVF).(12 Months follow-up)
- Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for ischemia-driven target-vessel revascularization (ID-TVR).(12 Months follow-up)
- Compare the predictive capacity of the post-PCI residual pressure gradients from pressure microcatheter versus pressure wire for target-vessel myocardial infarction (MI).(12 Months follow-up)
- Compare the rate of peri-procedural myocardial infarction stratified by PPG derived from pressure microcatheter versus pressure wire.(Periprocedural timeframe)
- Compare the rate of peri-procedural myocardial injury stratified by PPG derived from pressure microcatheter versus pressure wire.(Periprocedural timeframe)
- Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for target-vessel myocardial infarction (MI).(12 Months follow-up)
- Compare the predictive capacity of the post-PCI residual pressure gradients from pressure microcatheter versus pressure wire for target vessel revascularization.(12 Months follow-up)