Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions
Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions: the Multicenter OSTIAL-ANATOLIA Study
調査の概要
状態
詳細な説明
There are significant conceptual differences between accurate ostial stenting and crossover stenting strategies extending from the left main coronary artery to the target vessel. The isolated approach aims to avoid unnecessary left main coronary artery stenting, while the crossover technique aims to minimize the risk of residual stenosis by ensuring complete coverage of the ostial segment. However, the current literature presents inconsistent and heterogeneous results regarding the clinical superiority of these two approaches. The current evidence is based on retrospective analyses and observational records, and the lack of prospective and methodologically robust comparative studies is noteworthy. In this context, a prospective evaluation of these two strategies is critical not only for comparing clinical outcomes but also for standardizing the interventional approach. In particular, a systematic comparison based on clinically significant endpoints such as major adverse cardiovascular events (MACE), target lesion revascularization, and procedural success has the potential to fill the existing knowledge gap. This planned study aims to generate high-level evidence regarding which stenting strategy is superior in the treatment of left coronary artery ostial lesions. The findings are expected to make clinical decision-making processes more rational and evidence-based, and to improve patient prognosis. In this respect, the study has high potential for impact both in clinical practice and in the scientific literature.
This study aims to generate high-level evidence regarding which stenting strategy is superior in the treatment of ostial lesions of the left-sided coronary artery. It compares the 1-year clinical outcomes of patients treated with accurate ostial stenting and those treated with crossover stenting extending from the left main coronary artery to the target vessel.
The study was designed as a multicenter and prospective study between May 2026 and May 2027. Patients meeting the inclusion criteria who had critical ostial lesions of the left anterior descending artery and circumflex artery and underwent revascularization with accurate ostial stenting and crossover stenting extending from the left main coronary artery to the target vessel will be included. Patients will attend follow-up visits at 1 month, 6 months, and 12 months. At each visit, routine examinations will include biochemical parameters, ECG, and, if clinically necessary, ischemia investigation (exercise stress test, myocardial perfusion scintigraphy, coronary CT angiography) in the presence of ischemic symptoms. Control angiography will be performed if clinically necessary (>10% ischemia in scintigraphy, unstable angina pectoris, acute coronary syndrome). The following parameters will be recorded in detail in the study dataset for patients: age, gender, height, weight, Body Mass Index, smoking, diabetes mellitus, chronic renal failure, hypertension, hyperlipidemia, peripheral arterial disease, chronic obstructive pulmonary disease, left ventricular ejection fraction, symptoms, previous coronary intervention, multivessel disease, severe valvular disease, medical treatment parameters, procedural and angiographic parameters, 12-month mortality, myocardial Infarction, ee-intervention, stent thrombosis, and stroke.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Ahmet Güner, MD
- 電話番号:+90212692200
- メール:ahmetguner488@gmail.com
研究場所
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Istanbul、トルコ(Türkiye)、33484
- 募集
- İstanbul Mehmet Akif Ersoy Thoracic And Cardiovascular Surgery Training and Research Hospital
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コンタクト:
- Ahmet Güner
- 電話番号:05056533335
- メール:ahmetguner488@gmail.com
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Please Select
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Istanbul、Please Select、トルコ(Türkiye)、33484
- 積極的、募集していない
- Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Hospital
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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:
- Ostial left anterior descending artery or left circumflex artery disease
- Coronary intervention with second or third generation drug-eluting stent
Exclusion Criteria:
- Severe left main disease (≥30%, intravascular ultrasound plaque burden >50%)
- History of coronary bypass grafting
- Cardiogenic shock
- Left main diameter greater than stent expansion capacity (for crossover group)
- In-stent restenosis
- End-stage liver or kidney disease (cirrhosis, hemodialysis-dependent chronic kidney disease),
- Coronary intervention with bare-metal stent
- Early discontinuation or inappropriate use of DAPT treatment
- Patients lost to follow-up
- Patient life expectancy <1 year (such as cancer)
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 |
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Accurate Ostial Stenting
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Crossover Stenting
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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 |
|---|---|---|
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Major adverse cardiac event
時間枠:12 months
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Combination of cardiac death, target vessel myocardial infarction, or target lesion revascularization
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12 months
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協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
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
キーワード
その他の研究ID番号
- 2026.05-62
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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