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RecruitingNCT06931574Updated Apr 17, 2025

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

An observational study in Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI) and Bifurcation Coronary Disease, sponsored by Istanbul Mehmet Akif Ersoy Educational and Training Hospital. Recruiting at 2 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by Istanbul Mehmet Akif Ersoy Educational and Training Hospital · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

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

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03

In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's planned enrollment of 300 is below the median of 460 across 953 observational studies indexed under Coronary Disease.

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Lead sponsor

Istanbul Mehmet Akif Ersoy Educational and Training Hospital is the lead sponsor of 11 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Complex coronary bifurcation disease

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Controlled balloon-crush Group
  • Double kissing-crush stenting Group
06

What researchers measure

Primary outcomes

  1. Primary endpoint (Target lesion failure)

    Target lesion failure (%) is defined as the combination of cardiac death (%), target vessel myocardial infarction (%), or target lesion revascularization (%) rates.

    Time frame: 36 months

07

Study locations

2 of 2 sites recruiting
  • Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
    İstanbul, 33484, Turkey
    • Ahmet Güner, MD · Contact · ahmetguner488@gmail.com · 05056533335
    • Abdullah Doğan, MD · Contact · ahmetguner488@gmail.com
    • Abdullah Doğan, MD · Sub investigator
    • Ahmet Güner, MD · Sub investigator
    • Fatih Uzun, MD · Principal investigator
    • Hamdi Püşüroğlu, MD · Sub investigator
    • İrfan Şahin, MD · Sub investigator
    • Kudret Keskin, MD · Sub investigator
    • Ali Nazmi Çalık, MD · Sub investigator
    • Elnur Alizade, MD · Sub investigator
    • Veysel Ozan Tanık, MD · Sub investigator
    • Bilal Boztosun, MD · Sub investigator
    Recruiting
  • Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
    İstanbul, 33484, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06931574
Lead sponsor
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Collaborators
Sisli Hamidiye Etfal Training and Research Hospital, Başakşehir Çam & Sakura City Hospital, Bagcilar Training and Research Hospital, Ankara Etlik City Hospital, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Istanbul Medipol University Hospital
Responsible party
Ahmet Guner (Principal Investigator, Istanbul Mehmet Akif Ersoy Educational and Training Hospital) — Principal investigator
First posted
Apr 17, 2025
Start date
Apr 1, 2025
Primary completion
Nov 1, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 17, 2025

Study contacts

Fatih Uzun, Professor
Contact
fatihuzun28@gmail.com
902126922000
Abdullah Doğan, MD
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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