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

NCT07566403 | Not Yet Recruiting FDA Device

• 1 other identifier: OROBICA-2026-01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease (CAD); Calcific Coronary Arteriosclerosis; Intravascular Lithotripsy; Rotational Atherectomy; OFDI; Orbital Atherectomy; Optical Coherence Tomography (OCT); Intravascular Ultrasound; Percutaneous Coronary Intervention

Keywords

Coronary calcifications; coronary artery disease; percutaneous coronary intervention; intravascular imaging; atherectomy; intravascular lithotripsy; rotational atherectomy; orbital atherectomy; cutting balloon; target vessel failure

Outcome Measures

Primary Outcomes (1)

• Rate of Target Vessel Failure (TVF)

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

  1, 2 and 5 years

Secondary Outcomes (1)

• Rate of Major Adverse Cardiovascular Events (MACE)

  1, 2 and 5 years

Other Outcomes (3)

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

  30 days, 1, 2 and 5 years

• Total Procedural Costs and Healthcare Resource Utilization.

  From index procedure up to 12 months.

• Predictors of Severe Coronary Calcification and Procedural Complexity.

  Baseline (at the time of index procedure).

Study Arms (2)

Imaging group

Patients undergoing intravascular imaging-guided PCI

Procedure: Percutaneous coronary intervention with or without stent implantation

Debulking group

Patients undergoing PCI with advanced calcium-modification devices

Procedure: Percutaneous coronary intervention with or without stent implantation

Interventions

Percutaneous coronary intervention with or without stent implantation PROCEDURE

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

Debulking group; Imaging group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

ASST Papa Giovanni XXIII

Bergamo, Bergamo, 24127, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Francesco Moretti, MD

  Papa Giovanni XXIII Hospital, Bergamo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2036
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

IT (1)