RecruitingNCT06880978

Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions


Sponsor

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Enrollment

400 participants

Start Date

Mar 3, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Aged \>18
  • PCI with mini-crush or controlled balloon-crush
  • Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)

Exclusion Criteria9

  • 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

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Locations(1)

Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

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NCT06880978


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