Microvascular Obstruction Diagnosis Using the CoFI™ System Assessment - II
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Primary Effectiveness Endpoint
研究概览
简要总结
A prospective, multicenter, international single-arm, pivotal clinical study designed to validate the performance of the CoFI system in detecting MVO in STEMI subjects, as confirmed by CMRI. The study will be conducted in accordance with the Declaration of Helsinki, EN ISO 14155:2020, local and national regulations.
Each study site will receive support from a sponsor-certified proctor during the learning curve to ensure consistent and accurate application of the CoFI system.
详细描述
Microvascular obstruction (MVO) is a common complication that occurs after establishing coronary vessel patency by percutaneous coronary intervention (PCI) for the treatment of acute myocardial infarction (AMI).
Despite the successful restoration of vessel patency through PCI, 50% to 70% of STEMI subjects experience MVO, which affects vessels in the myocardial microcirculation. MVO occurs most commonly in the setting of AMI because the prolonged ischemia leads to endothelial damage, myocyte oedema and microvascular dysfunction.
Research has shown that MVO increases the risk of poor clinical outcomes, including death, re-infarction, reduced left ventricular ejection fraction (LVEF), left ventricular (LV) remodeling, heart failure, and more.
Late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMRI) is the current state-of-the-art for MVO identification and quantification. However, due to clinical reasons, CMRI imaging cannot be performed during the subject's emergent state. In most cases, this means that the diagnosis is made outside the biological window where MVO-related damage to heart muscle could be reversed or at least reduced.
Thus, although CMRI is the most accurate method to diagnose MVO, its use in routine practice is limited. Therefore, a direct and accurate quantitative diagnosis during primary PCI is required for early risk stratification in routine clinical practice.
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
- •Clinical:
- •Subject ≥18 years of age
- •Ability to provide written informed consent according to GCP and governing regulations
- •Diagnosis of acute anterior STEMI
- •Persistent symptoms to balloon time ≤ 6 hours. The assessment by the treating investigator after evaluation by subjects explanation is the defining timepoint for symptom onset.
- •PPCI & Angiographic
- •Culprit lesion in the LAD
- •COFI ballon can be placed according to IFU
- •Required stent diameter ≥ 2.75 mm and ≤ 5mm
- •Required stent length ≥ 15 mm
- •Successful PPCI Procedure as documented by <50% diameter residual angiographic stenosis within all treated culprit lesions with TIMI 2 or 3 flow.
排除标准
- •Clinical:
- •Cardiogenic shock
- •Thrombolytic therapy administered for this STEMI
- •Contraindication to CMRI
- •Cardiac pacemaker or implantable defibrillator;
- •Non-MRI compatible aneurysm clip;
- •Neural Stimulator (i.e., TENS unit);
- •Any implanted or magnetically activated device (insulin pump);
- •Any type of non-MRI compatible ear implant;
- •Metal shavings in the orbits;
- •Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
- •Any history indicating contraindication to MRI
- •Inability to follow breath hold instructions or to maintain a breath hold for >15 seconds; and
- •Known hypersensitivity or contraindication to gadolinium contrast.
- •Subject with previous MI and/or known cardiomyopathy (ischemic and non ischemic), ventricular pseudoaneurysm, VSD, severe mitral valve regurgitation (with or without papillary muscle rupture), severe known cardiac valvular stenosis or insufficiency, pericardial disease
- •Major bleeding ≤ 30d prior to intervention
- •Major surgery ≤ 30d prior to intervention
- •TIA or stroke ≤ 30d prior to intervention
- •Heart failure with inotrope support and/or consideration for LVAD or heart transplant
- •Known severe renal disease with creatinine > 2.5 mg/dL and/or eGFR < 30 mL/min/1.73 m2
- •Subject has other medical illness (e.g., cancer, dementia) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause non-compliance with the CIP, confound the data interpretation, or is associated with limited life expectancy of less than one year
- •Current participation in another clinical study
- •PPCI & Angiographic:
- •CABG of LAD
- •Unsuitable target vessel anatomy (excessive tortuosity, diffuse disease, or moderate/heavy calcification)
- •Cardiac condition preventing the use of the CoFI System
- •Any angiographic post stenting condition that according to the physician implies soc administration of any GpIIb/IIIa inhibitors or adenosine
- •Cardiac condition mandating elective PCI/CABG procedure prior to CMRI
结局指标
主要结局
Primary Effectiveness Endpoint
时间窗: From enrollment to the end of treatment at 6 Months
Diagnostic performance is measured by sensitivity and specificity of the CoFI system in detecting MVO in relation to the pre-set PCoFI threshold of 124 mmHg. The analysis will be per-protocol (PP) (primary) and the full analysis set (FAS) (secondary). Hypothesis Sensitivity and Specificity will be tested to meet the acceptance criteria: i.The lower bound of the confidence interval (CI) for sensitivity is 70% ii. The lower bound of the CI for specificity is 65% H0: p \< p0 H1: p ≥ p0 p0 = 70%se, 65%sp
次要结局
未报告次要终点