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NCT Number: NCT07596706

Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions

Coronary artery disease is a leading cause of mortality and morbidity globally. The left coronary artery system is critically important due to its supply of a large area of myocardium. Ostia lesions of left anterior descending artery [LAD] and circumflex artery [CX]) present technical challenges during percutaneous coronary intervention (PCI) and are considered high-risk lesions due to their anatomical location, relationship with the left main coronary artery bifurcation. Two main approaches exist for treating these lesions: accurate ostial stenting and crossover stenting extending from the left main coronary artery to the relevant branch. Accurate ostial stenting aims to avoid unnecessary stenting of the left main coronary artery, while crossover stenting is more advantageous in terms of ensuring complete coverage of the ostial region. However, the crossover approach may have disadvantages such as larger stent implantation and potential side branch involvement. The current literature does not clearly define the clinical superiority of these two strategies. While various studies have shown no significant difference in mortality, myocardial infarction, and target lesion revascularization, the results are heterogeneous, and a definitive consensus has not been reached. The majority of current data are based on retrospective or observational studies. Therefore, well-designed prospective studies comparing crossover stenting and accurate ostial stenting strategies in the ostial left-sided coronary artery (LAD and CX) lesions are needed. This planned study aims to contribute to this gap in the literature by comparing the clinical outcomes of the two approaches.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Hospital, Istanbul, Please Select, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Major adverse cardiac event

    Time frame: 12 months

    Combination of cardiac death, target vessel myocardial infarction, or target lesion revascularization

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Güner, MD

CONTACT

[email protected]

+90212692200

Sponsors and collaborators

Lead sponsor

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Other Gov

Collaborators

  • Abant Izzet Baysal University
  • Adana City Training and Research Hospital
  • Adiyaman University Research Hospital
  • Ahi Evran University Education and Research Hospital
  • Ankara City Hospital Bilkent
  • Ankara Etlik City Hospital
  • Bagcilar Training and Research Hospital
  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital
  • Başakşehir Çam & Sakura City Hospital
  • Bilecik Seyh Edebali Universitesi
  • Bursa City Hospital
  • Bursa Yuksek Ihtisas Training and Research Hospital
  • Dicle University
  • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
  • Ege University
  • Haseki Training and Research Hospital
  • Hitit University
  • Istanbul Medipol University Hospital
  • Istanbul Training and Research Hospital
  • Izmir Bakircay University
  • Kocaeli University
  • Kosuyolu Heart Hospital
  • Kutahya City Hospital
  • Medipol University
  • Mersin City Hospital
  • Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  • Samsun Education and Research Hospital
  • Siirt Training and Research Hospital
  • Sisli Hamidiye Etfal Training and Research Hospital
  • Trakya University
  • Van Training and Research Hospital
  • Yalova training and research hospital

Registry information

Official study title

Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions: the Multicenter OSTIAL-ANATOLIA Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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