Clinical trial NCT06880978: Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions
Official title: Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Bifurcation Lesions
Death
Myocardial Infarction (MI)
Stent Thrombosis
Stroke
Keywords: Coronary bifurcation
death
revascularization
stenting
Lead sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Istanbul Medipol University Hospital
name: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Başakşehir Çam & Sakura City Hospital
name: Sisli Hamidiye Etfal Training and Research Hospital
name: Ankara Etlik City Hospital
name: Ankara City Hospital Bilkent
name: Istanbul University - Cerrahpasa
name: Trakya University
name: Cigli Regional Training Hospital
name: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
name: İstanbul Bağcılar Training and Research Hospital
First posted: 2025-03-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Complex coronary bifurcation disease

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 12-months
Secondary outcomes:
measure: Major adverse cardiovascular and cerebral events (MACCE)
timeFrame: 12-months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
Study officials:
References: