Coronary Bifurcation Lesions, Death, Myocardial Infarction (MI), Stent Thrombosis, Stroke
Conditions
Keywords
Coronary bifurcation, death, revascularization, stenting
Brief summary
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.
Interventions
None listed
Sponsors
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
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged \>18 * PCI with mini-crush or controlled balloon-crush * Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)
Exclusion criteria
* Non-complex bifurcation anatomy * Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush) * ST-elevation myocardial infarction * Cardiogenic shock status * In-stent restenosis * A history of coronary artery bypass grafting * Implantation of bare-metal stent * End-stage hepatic or renal disease * \<1-year life expectancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac events (MACE) | 12-months | 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
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular and cerebral events (MACCE) | 12-months | 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 (%). |
Countries
Turkey (Türkiye)
Contacts
Primary ContactFatih Uzun, Professor
Backup ContactAhmet Güner, MD
Outcome results
None listed