Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.

Обзор

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.

Вмешательства

• Процедура Percutaneous coronary intervention with or without stent implantation
  In this registry patients will undergo PCI of severely calcified coronary arteries

Первичные конечные точки

• Rate of Target Vessel Failure (TVF) [Срок оценки: 1, 2 and 5 years]

Вторичные конечные точки (1)

• Rate of Major Adverse Cardiovascular Events (MACE) [Срок оценки: 1, 2 and 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• ASST Papa Giovanni XXIII — Bergamo

Идентификаторы

NCT: NCT07566403 · OROBICA-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗