About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged >18
PCI with mini-crush or controlled balloon-crush
Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)
Disqualifiers
Non-complex bifurcation anatomy
Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush)
ST-elevation myocardial infarction
Cardiogenic shock status
Trial population
Complex coronary bifurcation disease
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Major adverse cardiac events (MACE)
The primary endpoint is defined as the composite of the rates of major adverse cardiac events (MACE) (%) including cardiac death (%), target vessel myocardial infarction (%), and target lesion revascularization (%).
Secondary outcomes
Major adverse cardiovascular and cerebral events (MACCE)
The secondary endpoint (clinical) is defined as the composite of the rates of major adverse cardiac and cerebral events (MACCE) (%) including all-cause death (%), target vessel myocardial infarction (%), target lesion revascularization (%), probable or definite stent thrombosis (%), or stroke (%).
Sponsors and contacts
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Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Lead sponsor
Istanbul Medipol University Hospital
Collaborator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Collaborator
Başakşehir Çam & Sakura City Hospital
Collaborator
Sisli Hamidiye Etfal Training and Research Hospital
Collaborator
Ankara Etlik City Hospital
Collaborator
Ankara City Hospital Bilkent
Collaborator
Istanbul University - Cerrahpasa
Collaborator
Trakya University
Collaborator
Cigli Regional Training Hospital
Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Collaborator
İstanbul Bağcılar Training and Research Hospital
Collaborator