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NCT Number: NCT06880978

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Istanbul, 33484, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ahmet Arif Yalçın, MD

SUB_INVESTIGATOR

Ahmet Güner, MD

CONTACT

[email protected]

05056533335

Ahmet Karaduman, MD

SUB_INVESTIGATOR

Ali Nazmi Çalık, MD

SUB_INVESTIGATOR

Aykun Hakgör, MD

SUB_INVESTIGATOR

Bilal Boztosun, MD

SUB_INVESTIGATOR

Fatih Uzun, MD

PRINCIPAL_INVESTIGATOR

Gökhan Çiçek, MD

SUB_INVESTIGATOR

Hamdi Püşüroğlu, MD

SUB_INVESTIGATOR

Hasan Ali Barman, MD

SUB_INVESTIGATOR

Kudret Keskin, MD

SUB_INVESTIGATOR

Mehmet Baran Karataş, MD

SUB_INVESTIGATOR

Murat Gök, MD

SUB_INVESTIGATOR

Veysel Ozan Tanık, MD

SUB_INVESTIGATOR

İbrahim Faruk Aktürk, MD

SUB_INVESTIGATOR

İlker Gül, MD

SUB_INVESTIGATOR

İrfan Şahin, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: 12-months

    The primary endpoint is defined as the composite of the rates of major adverse cardiac events (MACE) (%) including cardiac death (%), target vessel myocardial infarction (%), and target lesion revascularization (%).

Secondary outcomes

  1. Major adverse cardiovascular and cerebral events (MACCE)

    Time frame: 12-months

    The secondary endpoint (clinical) is defined as the composite of the rates of major adverse cardiac and cerebral events (MACCE) (%) including all-cause death (%), target vessel myocardial infarction (%), target lesion revascularization (%), probable or definite stent thrombosis (%), or stroke (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmet Güner, MD

CONTACT

[email protected]

+90 2126922000

Fatih Uzun, Professor

CONTACT

[email protected]

+90 5057705766

Sponsors and collaborators

Lead sponsor

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Other Gov

Collaborators

  • Ankara City Hospital Bilkent
  • Ankara Etlik City Hospital
  • Başakşehir Çam & Sakura City Hospital
  • Cigli Regional Training Hospital
  • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
  • Istanbul Medipol University Hospital
  • Istanbul University - Cerrahpasa
  • Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
  • Sisli Hamidiye Etfal Training and Research Hospital
  • Trakya University
  • İstanbul Bağcılar Training and Research Hospital

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 18, 2025
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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