Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry. (OROBICA)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Bergamo
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Bergamo, Bergamo, Italia, 24127
- Asst Papa Giovanni Xxiii
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Ta kontakt med:
- Francesco Moretti, MD
- Telefonnummer: +39 0352678249
- E-post: f.moretti@asst-pg23.it
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Ta kontakt med:
- Elena Zattoni, MSc
- Telefonnummer: +39 0352673452
- E-post: zattoni.elena@asst-pg23.it
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Imaging group
Patients undergoing intravascular imaging-guided PCI
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In this registry patients will undergo PCI of severely calcified coronary arteries
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Debulking group
Patients undergoing PCI with advanced calcium-modification devices
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In this registry patients will undergo PCI of severely calcified coronary arteries
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of Target Vessel Failure (TVF)
Tidsramme: 1, 2 and 5 years
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Defined as composite of Cardiac Death, Target vessel Myocardial Infarction and Clinically-Driven Target Vessel Revascularization
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1, 2 and 5 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of Major Adverse Cardiovascular Events (MACE)
Tidsramme: 1, 2 and 5 years
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Defined as composite of all-cause death, myocardial infarction (MI), stroke, clinically-driven target vessel revascularisation (CD-TVR) and hospitalization for cardiovascular causes
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1, 2 and 5 years
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of MACE and Repeat Revascularization across Calcium Modification Techniques.
Tidsramme: 30 days, 1, 2 and 5 years
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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.
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30 days, 1, 2 and 5 years
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Total Procedural Costs and Healthcare Resource Utilization.
Tidsramme: From index procedure up to 12 months.
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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.
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From index procedure up to 12 months.
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Predictors of Severe Coronary Calcification and Procedural Complexity.
Tidsramme: Baseline (at the time of index procedure).
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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.
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Baseline (at the time of index procedure).
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Francesco Moretti, MD, Papa Giovanni XXIII Hospital, Bergamo
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Hjertesykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Koronar sykdom
- Myokardiskemi
- Koronararteriesykdom
- Kirurgiske prosedyrer, operativ
- Endovaskulære prosedyrer
- Vaskulære kirurgiske inngrep
- Kardiovaskulære kirurgiske inngrep
- Minimalt invasive kirurgiske inngrep
- Perkutan koronar intervensjon
Andre studie-ID-numre
- OROBICA-2026-01
Plan for individuelle deltakerdata (IPD)
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