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

4. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

3000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Target Vessel Failure (TVF)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of Major Adverse Cardiovascular Events (MACE)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of MACE and Repeat Revascularization across Calcium Modification Techniques.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Papa Giovanni XXIII Hospital

Efterforskere

  • Ledende efterforsker: Francesco Moretti, MD, Papa Giovanni XXIII Hospital, Bergamo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juni 2026

Primær færdiggørelse (Anslået)

30. juni 2028

Studieafslutning (Anslået)

30. juni 2036

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • OROBICA-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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