Clinical trial NCT06546748: Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions
Official title: Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions: The EVOLUTE-CRUSH Left Main Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Main Coronary Artery Disease
Lead sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Koşuyolu Kartal Heart Training and Research Hospital
name: Basaksehir Cam & Sakura City Hospital
name: Medipol University
name: Sisli Hamidiye Etfal Training and Research Hospital
name: Bağcılar Training and Research Hospital
name: Ankara Etlik City Hospital
name: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
First posted: 2024-08-09
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This multicenter observational study was retrospectively conducted between January 2014 and January 2024, and patients who underwent percutaneous coronary intervention (PCI) for complex left main coronary bifurcation lesions.

Brief summary: The Crush technique has evolved significantly since its introduction to the literature by Colombo et al in 2003, with multiple iterations including mini-crush (MC) and double kissing-crush (DKC) stenting techniques. The main principle of crush techniques for complex bifurcation lesions is to protrude the side branch (SB) stent towards the main branch to adequately cover the SB ostium and minimize the risk of SB ostium restenosis. It was noticed that the 4-5 mm protrusion of the SB stent resulted in a large volume of the crushed stent and the technique was modified into MC which aimed for approximately 1-2 mm protrusion by Galassi et al in 2007. Despite all the disadvantages of the crush technique, the final kissing balloon inflation (KBI) rate of this technique, along with several iterations has been up to 98%. Moreover, a recent meta-analysis showed that MC was associated with a reduction in risk of major cardiovascular events compared to provisional stenting, crush, and culotte techniques. The DKC is a planned 2-stent technique introduced by Chen et al. The ultimate innovation of this approach is that it is designed to increase the success rate of the final KBI. Provided recrossing of the crushed stent occurs through the proximal cell: another advantage of the DKC technique is to improve the success of KBI. The DKC significantly reduced major cardiovascular events (MACE) compared to provisional stenting, crush, TAP, and culotte. Until now, no clinical investigation has compared the DKC and MC in patients with complex left main bifurcation lesions. Therefore, this study sought to determine the clinical results of DKC and MC stenting techniques under long-term follow-up.


Eligibility criteria: Inclusion Criteria:

* true complex left main bifurcation lesions
* stenting with double kissing-crush or mini-crush as a 2-stent strategy
* participation in regular clinical follow-up

Exclusion Criteria:

* prior history of coronary artery bypass grafting
* cardiogenic shock
* end-stage liver or kidney disease
* allergy to antiplatelet therapy or contrast media
* inappropriate dual antiplatelet therapy
* critically ill with \< 1-year life expectancy
* absence of all medical records
* PCI for ST-segment elevation myocardial infarction or in-stent restenosis
* non-complex bifurcation lesions
* treated with a bare metal stent

Primary outcomes:
measure: Major cardiovascular events (MACE)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ahmet Güner
Study officials:
References: