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

NCT07566403 · tracked via the Priya Life Science Italy tracker

Sponsor

Papa Giovanni XXIII Hospital

Phase

Observational

Started

2026-06-30

Last updated

2026-05-06

Condition(s) studied

Coronary Artery Disease (CAD)Calcific Coronary ArteriosclerosisIntravascular Lithotripsy; Rotational Atherectomy; OFDIOrbital AtherectomyOptical Coherence Tomography (OCT)Intravascular UltrasoundPercutaneous Coronary Intervention

Investigational drug(s) / intervention(s)

Percutaneous coronary intervention with or without stent implantation

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Rate of Target Vessel Failure (TVF) — 1, 2 and 5 years
Defined as composite of Cardiac Death, Target vessel Myocardial Infarction and Clinically-Driven Target Vessel Revascularization

Trial sites (1)

Facility	City	Region	Status
ASST Papa Giovanni XXIII	Bergamo	Bergamo

More Papa Giovanni XXIII Hospital trials in Italy

Camera-based Endoscopy Allows Spontaneous Breathing Diagnostic Management in Neonates With Tracheoesophageal Fistula Recruiting

Long Term Safety of Preoperative Percutaneous Intercostal Cryoneurolysis Recruiting

Percutaneous Intercostal Cryoneuromodulation Onset Timing. Recruiting

Other trials for the same condition

SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective Recruiting

Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry Enrolling by invitation

AGECTO Study: PCI vs. Optimal Medical Therapy for CTO in the Octogenarian Patients Active, not recruiting

Naples PCI Registry Recruiting

Evaluating the Role of IGF-1 and S-Klotho In Plaque Phenotype and Vulnerability: the VISION Study. Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07566403 on ClinicalTrials.gov ↗ ← All trials in Italy