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

May 4, 2026 updated by: Francesco Moretti, Papa Giovanni XXIII Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Imaging group
Patients undergoing intravascular imaging-guided PCI
Procedure: Percutaneous coronary intervention with or without stent implantation
In this registry patients will undergo PCI of severely calcified coronary arteries
Debulking group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 2 and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 2 and 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days, 1, 2 and 5 years
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.
From index procedure up to 12 months.
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.
Baseline (at the time of index procedure).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papa Giovanni XXIII Hospital

Investigators

  • Principal Investigator: Francesco Moretti, MD, Papa Giovanni XXIII Hospital, Bergamo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2036

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OROBICA-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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