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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorIstanbul Mehmet Akif Ersoy Educational and Training Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Ostial left anterior descending artery or left circumflex artery disease

Coronary intervention with second or third generation drug-eluting stent

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Lead sponsor

Yalova training and research hospital

Collaborator

Mersin City Hospital

Collaborator

Van Training and Research Hospital

Collaborator

Başakşehir Çam & Sakura City Hospital

Collaborator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Collaborator

Trakya University

Collaborator

Sisli Hamidiye Etfal Training and Research Hospital

Collaborator

Istanbul Training and Research Hospital

Collaborator

Medipol University

Collaborator

Samsun Education and Research Hospital

Collaborator

Kocaeli University

Collaborator

Abant Izzet Baysal University

Collaborator

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Collaborator

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Collaborator

Bagcilar Training and Research Hospital

Collaborator

Ankara City Hospital Bilkent

Collaborator

Dicle University

Collaborator

Bursa Yuksek Ihtisas Training and Research Hospital

Collaborator

Haseki Training and Research Hospital

Collaborator

Ahi Evran University Education and Research Hospital

Collaborator

Ankara Etlik City Hospital

Collaborator

Izmir Bakircay University

Collaborator

Istanbul Medipol University Hospital

Collaborator

Kutahya City Hospital

Collaborator

Adiyaman University Research Hospital

Collaborator

Adana City Training and Research Hospital

Collaborator

Kosuyolu Heart Hospital

Collaborator

Ege University

Collaborator

Bursa City Hospital

Collaborator

Bilecik Seyh Edebali Universitesi

Collaborator

Siirt Training and Research Hospital

Collaborator

Hitit University

Collaborator