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NCT Number: NCT07566403

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

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.

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Calcific Coronary Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Intravascular Lithotripsy; Rotational Atherectomy; OFDI Intravascular Ultrasound Myocardial Ischemia Optical Coherence Tomography (OCT) Orbital Atherectomy Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Percutaneous coronary intervention with or without stent implantation

Procedure

In this registry patients will undergo PCI of severely calcified coronary arteries

Primary outcomes

  1. Rate of Target Vessel Failure (TVF)

    Time frame: 1, 2 and 5 years

    Defined as composite of Cardiac Death, Target vessel Myocardial Infarction and Clinically-Driven Target Vessel Revascularization

Secondary outcomes

  1. Rate of Major Adverse Cardiovascular Events (MACE)

    Time frame: 1, 2 and 5 years

    Defined as composite of all-cause death, myocardial infarction (MI), stroke, clinically-driven target vessel revascularisation (CD-TVR) and hospitalization for cardiovascular causes

Other outcomes

  1. Rate of MACE and Repeat Revascularization across Calcium Modification Techniques.

    Time frame: 30 days, 1, 2 and 5 years

    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.

  2. Total Procedural Costs and Healthcare Resource Utilization.

    Time frame: From index procedure up to 12 months.

    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.

  3. Predictors of Severe Coronary Calcification and Procedural Complexity.

    Time frame: Baseline (at the time of index procedure).

    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.

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Acronym: OROBICA

Important dates

Study start
2026
Primary completion
2028
Study completion
2036
First posted
May 5, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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