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

NCT06931574 | Recruiting

• 1 other identifier: 2025.03-21
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

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.

  36 months

Study Arms (2)

Controlled balloon-crush Group

Double kissing-crush stenting Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Complex coronary bifurcation disease

You may qualify if:

• Aged \>18
• PCI with either DK-crush or Controlled balloon-crush
• Complex coronary bifurcation lesion (Medina 0.1.1, Medina 1.1.1)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

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

Istanbul, 33484, Turkey (Türkiye)

RECRUITING

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

Istanbul, 33484, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Fatih Uzun, Professor

CONTACT

902126922000; fatihuzun28@gmail.com

Abdullah Doğan, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 17, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

TU (2)