Clinical trial NCT06931574: Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions
Official title: Comparison of Cardiovascular Outcomes of Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bifurcation Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Bifurcation Coronary Disease
Lead sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Sisli Hamidiye Etfal Training and Research Hospital
name: Başakşehir Çam & Sakura City Hospital
name: Bagcilar Training and Research Hospital
name: Ankara Etlik City Hospital
name: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
name: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Istanbul Medipol University Hospital
First posted: 2025-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Complex coronary bifurcation disease

Brief summary: The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation. The main disadvantage of the historical Crush technique is the low success rate of the final kissing balloon inflation. An improvement came with the introduction of double kissing crush stenting aiming for the shorter protrusion and kissing balloon dilation performed before and after main branch stent implantation. The double kissing crush provides a significant reduction in major adverse cardiovascular events compared to Provisional stenting, Crush, and Culotte techniques. Recently, a novel modified mini-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. To date, no data compares the mid-term outcomes of double kissing crush and controlled balloon-crush stenting techniques in patients with complex coronary bifurcation lesions. Hence, this study aimed to determine the clinical results of double kissing crush and controlled balloon-crush techniques under mid-term follow-up.


Eligibility criteria: Inclusion Criteria:

* Aged \>18
* PCI with either DK-crush or Controlled balloon-crush
* Complex coronary bifurcation lesion (Medina 0.1.1, Medina 1.1.1)

Exclusion Criteria:

* Non-complex bifurcation anatomy
* Bail-out 2-stent (reverse modified mini-crush)
* ST-elevation myocardial infarction
* Cardiogenic shock status
* In-stent restenosis
* A previous of coronary artery bypass grafting
* Implantation of bare-metal stent
* End-stage hepatic or renal disease
* \<1-year life expectancy

Primary outcomes:
measure: Primary endpoint (Target lesion failure)
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
city: İstanbul
country: Turkey
facility: Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
Study officials:
References: