Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Rate of Target Vessel Failure (TVF)
研究概览
简要总结
The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural, imaging, and economic outcomes of patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary artery disease.
Coronary artery calcification represents one of the main determinants of procedural complexity and adverse outcomes in contemporary interventional cardiology. Despite the increasing availability of advanced calcium-modification technologies and intracoronary imaging techniques, evidence regarding the optimal treatment strategy in real-world clinical practice remains limited, particularly among high-risk and complex patients often underrepresented in randomized trials.
The OROBICA Registry aims to systematically collect longitudinal data from all-comer patients treated for severely calcified coronary lesions using contemporary PCI strategies, including intracoronary imaging guidance (IVUS/OCT), rotational atherectomy, orbital atherectomy, intravascular lithotripsy, specialty balloons, and combined calcium-modification approaches.
The primary objective is to assess clinical and procedural outcomes, with particular focus on target vessel failure (TVF). Secondary and exploratory objectives include evaluation of procedural success, imaging findings, predictors of adverse outcomes, healthcare resource utilization, and economic impact associated with the treatment of calcified coronary lesions.
The registry is designed as a flexible research platform intended to support future hypothesis-generating analyses and provide real-world evidence to improve personalized management strategies for calcified coronary artery disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary lesions, angiographically defined as radiopacities noted without cardiac motion before contrast injection, generally involving both sides of the arterial wall.
- •Patients undergoing PCI for calcified coronary lesions with intracoronary optical coherence tomography (OCT) showing at least one of the following features:
- •calcium arc ≥180°
- •calcium thickness ≥0.3 mm
- •calcium length ≥3 mm
- •presence of calcified nodules
- •Patients undergoing PCI for calcified coronary lesions with intravascular ultrasound (IVUS) showing at least one of the following features:
- •calcium arc ≥180°
- •concentric or superficial calcium with extensive acoustic shadowing
- •presence of calcified nodules
排除标准
- •Lack of availability of essential clinical or procedural data.
- •Refusal or withdrawal of informed consent for the prospective component of the registry, when applicable.
- •Exercise of the right to object to data processing, according to applicable data protection regulations.
研究组 & 干预措施
Debulking group
Patients undergoing PCI with advanced calcium-modification devices
干预措施: Percutaneous coronary intervention with or without stent implantation (Procedure)
Imaging group
Patients undergoing intravascular imaging-guided PCI
干预措施: Percutaneous coronary intervention with or without stent implantation (Procedure)
结局指标
主要结局
Rate of Target Vessel Failure (TVF)
时间窗: 1, 2 and 5 years
Defined as composite of Cardiac Death, Target vessel Myocardial Infarction and Clinically-Driven Target Vessel Revascularization
次要结局
- Rate of Major Adverse Cardiovascular Events (MACE)(1, 2 and 5 years)
研究者
Francesco Moretti
Principal Investigator
Papa Giovanni XXIII Hospital