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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Bergamo
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Bergamo、Bergamo、イタリア、24127
- ASST Papa Giovanni XXIII
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コンタクト：
- Francesco Moretti, MD
- 電話番号：+39 0352678249
- メール：f.moretti@asst-pg23.it
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コンタクト：
- Elena Zattoni, MSc
- 電話番号：+39 0352673452
- メール：zattoni.elena@asst-pg23.it
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of Target Vessel Failure (TVF)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of Major Adverse Cardiovascular Events (MACE)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Rate of MACE and Repeat Revascularization across Calcium Modification Techniques.
時間枠：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.
時間枠：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.
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Francesco Moretti, MD、Papa Giovanni XXIII Hospital, Bergamo
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OROBICA-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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米国で製造され、米国から輸出された製品。
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