Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions

The mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive cardiologists. Moreover, mini-crush and double kissing-crush techniques have been compared in terms of clinical results in both left main and non-left main coronary bifurcation patient populations and no significant difference was found. However, the most important challenges of the mini-crush technique are the rewiring and advancement of a 1:1 non-compliant side-branch balloon after the main branch stent has been implanted. These challenges usually necessitate the use of a low profile balloon or additional support maneuvers (such as anchor balloon). Recently, a novel modified mini-crush-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon) and this causes less disruption of the stent cells. This prospective observational study aims to assess the procedural and 1-year clinical outcomes of the contemporary mini-crush and controlled balloon-crush (modified mini-crush) double stenting techniques in patients with true coronary bifurcation lesions.

NCT Number	NCT06880978
Lead Sponsor	Istanbul Mehmet Akif Ersoy Educational and Training Hospital Collaborators: Istanbul Medipol University Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Başakşehir Çam & Sakura City Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Ankara Etlik City Hospital, Ankara City Hospital Bilkent, Istanbul University - Cerrahpasa, Trakya University, Cigli Regional Training Hospital, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital, İstanbul Bağcılar Training and Research Hospital
Conditions	Coronary Bifurcation Lesions, Death, Myocardial Infarction (MI), Stent Thrombosis, Stroke
Enrollment	400 participants
Start Date	2025-03-03
Primary Completion	2025-08-01 (estimated)
Study Completion	2026-08-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-18