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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06931574
Enrollment
300
Registered
2025-04-17
Start date
2025-04-01
Completion date
2026-12-30
Last updated
2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

None listed

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
CollaboratorOTHER
Başakşehir Çam & Sakura City Hospital
CollaboratorOTHER_GOV
Bagcilar Training and Research Hospital
CollaboratorOTHER_GOV
Ankara Etlik City Hospital
CollaboratorOTHER_GOV
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
CollaboratorOTHER_GOV
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
CollaboratorOTHER
Istanbul Medipol University Hospital
CollaboratorOTHER
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Primary endpoint (Target lesion failure)36 monthsTarget lesion failure (%) is defined as the combination of cardiac death (%), target vessel myocardial infarction (%), or target lesion revascularization (%) rates.

Countries

Turkey (Türkiye)

Contacts

Backup ContactAbdullah Doğan, MD
Primary ContactFatih Uzun, Professor
fatihuzun28@gmail.com902126922000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026