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NCT07596706
Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions
Conditions: Coronary Bifurcation Lesion, Coronary Artery Disease (CAD), Left Main Coronary Artery Stenosis
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Enrollment: 1000
Sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Location: Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Hospital Istanbul Please Select
Summary
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
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 \
Source: ClinicalTrials.gov (NCT07596706). StuddyBuddy aggregates publicly available trial information.