CT-PROVE: Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
The goal of this clinical trial is to learn whether coronary CT angiography (CCTA)-guided planning improves the efficiency and outcomes of percutaneous coronary intervention (PCI) in adults with coronary artery disease. It will also evaluate the feasibility and safety of using a CT-based "virtual PCI plan" during coronary interventions.
The main questions it aims to answer are:
- Does CCTA-guided PCI reduce procedural time, radiation exposure, and contrast dye use compared with standard PCI?
- Does CCTA-guided PCI improve procedural outcomes and stent optimization?
- How often do operators follow or deviate from the CT-based procedural plan?
- What medical problems or complications occur during and after CCTA-guided PCI?
Researchers will compare CCTA-guided PCI with standard angiography-guided PCI to determine whether CT-derived procedural planning improves PCI efficiency and clinical outcomes.
Participants will:
- Undergo PCI guided either by a CCTA-based virtual planning strategy or by standard clinical practice
- Attend follow-up assessments at 1 month, 6 months, and 1 year
- Undergo routine clinical evaluations and imaging assessments related to their PCI procedure
- Be monitored for procedural complications, symptoms, repeat procedures, and cardiovascular outcomes during follow-up
The study will also include a parallel observational registry for patients whose coronary lesions are deferred from PCI, to evaluate their long-term clinical outcomes.
详细描述
Coronary artery disease (CAD) remains one of the leading causes of morbidity and mortality worldwide. Percutaneous coronary intervention (PCI) is routinely performed to treat obstructive CAD; however, conventional invasive coronary angiography provides limited information regarding plaque morphology, lesion composition, calcium distribution, vessel remodeling, and functional lesion significance. These limitations may affect procedural planning, device selection, procedural efficiency, and final PCI optimization.
Coronary computed tomography angiography (CCTA) has evolved into a comprehensive non-invasive imaging modality capable of providing detailed anatomical and functional assessment of coronary lesions. In addition to defining stenosis severity, CCTA allows assessment of lesion length, vessel dimensions, plaque morphology, high-risk plaque characteristics, calcium burden, bifurcation anatomy, and vessel trajectory. Furthermore, computational fluid dynamics enable the derivation of CT-based fractional flow reserve (CT-FFR), providing a non-invasive estimation of lesion-specific ischemia.
The CT-PROVE trial (Computed Tomography Angiography Based Procedural Planning in PeRcutaneOus Coronary InterVEntion) is a prospective, multicenter, randomized, controlled, open-label clinical trial designed to evaluate the implementation of a CCTA-derived virtual PCI planning strategy during invasive coronary intervention. The study aims to determine whether integrating a structured CT-based procedural planning workflow into PCI practice improves procedural efficiency and procedural outcomes compared with standard angiography-guided PCI.
Patients with chronic coronary syndrome or stabilized acute coronary syndrome who undergo clinically indicated CCTA and are subsequently referred for invasive coronary angiography will be screened for enrollment. Eligible patients presenting with at least one target lesion meeting predefined anatomical and/or functional criteria on CCTA will be considered for inclusion.
The study consists of two randomized groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an open-label trial in which operators performing PCI are aware of treatment allocation after randomization. Participants and treating physicians are not blinded to the assigned intervention. However, assessment of procedural and imaging-related endpoints, including quantitative coronary angiography (QCA), quantitative flow ratio (QFR), angiographic complications, and procedural outcomes, will be performed by a centralized core laboratory blinded to treatment allocation. In the control arm, operators will remain blinded to the advanced CCTA-derived virtual PCI planning throughout the procedure to avoid influencing procedural decision-making.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 years
- •Ability to provide written informed consent
- •Patients undergoing coronary computed tomography angiography (CCTA) for suspected coronary artery disease or for diagnostic work-up of stabilized acute coronary syndrome
- •Presence of at least one target coronary lesion meeting one of the following CCTA criteria:
- •Severe coronary diameter stenosis (70-99%) in one or more coronary arteries according to CAD-RADS 4A or 4B classification and at least one of the following:
- •CT-derived fractional flow reserve (CT-FFR) ≤0.80
- •At least 2 high-risk plaque characteristics, including:
- •Low attenuation plaque density <30 Hounsfield units
- •Positive remodeling index >1.1
- •Napkin-ring sign
- •Spotty calcification
- •Left main coronary artery stenosis ≥50%
- •Ostial or proximal left anterior descending artery, dominant left circumflex artery, or dominant right coronary artery stenosis ≥50% and at least one of the following:
- •CT-FFR ≤0.80
- •At least 2 high-risk plaque characteristics, including:
- •Low attenuation plaque density <30 Hounsfield units
- •Positive remodeling index >1.1
- •Napkin-ring sign
- •Spotty calcification
- •Planned clinically indicated invasive coronary angiography with operator decision to proceed with PCI
排除标准
- •Contraindication to iodinated contrast media, including severe allergy or contrast-induced nephropathy
- •Poor-quality or non-diagnostic CCTA imaging
- •Target lesions involving in-stent restenosis
- •Chronic total occlusion target lesions
- •Operator decision to treat a vessel not identified as a target vessel by the CCTA core laboratory analysis
- •Pregnancy or breastfeeding
- •Patients referred for coronary artery bypass graft surgery after invasive coronary angiography
- •Participation in another investigational drug or drug-coated device study
- •Inability to provide informed consent
研究者
Faisal Sharif
Prof. Faisal Sharif
University of Galway