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NCT Number: NCT06546748

Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmet Güner

Istanbul, Turkey, 33484, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major cardiovascular events (MACE)

    Time frame: 12 months

    Cardiac death, clinically-driven target lesion revascularization, target vessel myocardial infarction

Sponsors and collaborators

Lead sponsor

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Other Gov

Collaborators

  • Ankara Etlik City Hospital
  • Basaksehir Cam & Sakura City Hospital
  • Bağcılar Training and Research Hospital
  • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
  • Koşuyolu Kartal Heart Training and Research Hospital
  • Medipol University
  • Sisli Hamidiye Etfal Training and Research Hospital

Registry information

Official study title

Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions: The EVOLUTE-CRUSH Left Main Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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