An observational study in Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis and Intravascular Lithotripsy; Rotational Atherectomy; OFDI, sponsored by Papa Giovanni XXIII Hospital. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Papa Giovanni XXIII Hospital · Observational
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.
The OROBICA Registry will include adult patients undergoing percutaneous coronary intervention (PCI) for severely calcified coronary artery disease in routine clinical practice. The study population consists of all-comer patients treated for complex calcified coronary lesions, including individuals with stable coronary artery disease, acute coronary syndromes, multivessel disease, left main disease, bifurcation lesions, chronic total occlusions, and high-risk clinical or anatomical features.
Patients undergoing PCI for calcified coronary lesions with intracoronary optical coherence tomography (OCT) showing at least one of the following features:
Patients undergoing PCI for calcified coronary lesions with intravascular ultrasound (IVUS) showing at least one of the following features:
Exclusion Criteria:
Patients undergoing intravascular imaging-guided PCI
Procedure: Percutaneous coronary intervention with or without stent implantation
Patients undergoing PCI with advanced calcium-modification devices
Procedure: Percutaneous coronary intervention with or without stent implantation
In this registry patients will undergo PCI of severely calcified coronary arteries
Rate of Target Vessel Failure (TVF)
Defined as composite of Cardiac Death, Target vessel Myocardial Infarction and Clinically-Driven Target Vessel Revascularization
Time frame: 1, 2 and 5 years
Rate of Major Adverse Cardiovascular Events (MACE)
Defined as composite of all-cause death, myocardial infarction (MI), stroke, clinically-driven target vessel revascularisation (CD-TVR) and hospitalization for cardiovascular causes
Time frame: 1, 2 and 5 years
Rate of MACE and Repeat Revascularization across Calcium Modification Techniques.
Evaluation of the incidence of Major Adverse Cardiovascular Events (MACE) and Target Lesion Revascularization (TLR) in relation to the specific calcium modification strategy used: rotational atherectomy, orbital atherectomy, intravascular lithotripsy (IVL), excimer laser, or combined strategies.
Time frame: 30 days, 1, 2 and 5 years
Total Procedural Costs and Healthcare Resource Utilization.
Assessment of total economic burden including costs of specific interventional materials/devices, total procedure duration, length of index hospital stay, and rate of all-cause hospital readmissions.
Time frame: From index procedure up to 12 months.
Predictors of Severe Coronary Calcification and Procedural Complexity.
Identification of clinical, angiographic, intravascular imaging, and biochemical markers (e.g., renal function, calcium-phosphorus metabolism) associated with the presence of severe calcification and the requirement for advanced calcium modification tools.
Time frame: Baseline (at the time of index procedure).
Plan to share: Undecided
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Papa Giovanni XXIII Hospital