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Recruiting NCT06931574

Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions

Observational Coronary Arterial Disease (CAD) Percutaneous Coronary Intervention (PCI) Bifurcation Coronary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Cardiovascular Outcomes of Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bifurcation Lesions

Overview

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.

Primary outcome measures

  • Primary endpoint (Target lesion failure) [Time frame: 36 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 2 centers
  • Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospi — Istanbul
  • Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospi — Istanbul

Identifiers

NCT: NCT06931574 · 2025.03-21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗