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

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.

Study Overview

• Status: Recruiting
• Conditions: Bifurcation Coronary Disease; Percutaneous Coronary Intervention (PCI); Coronary Arterial Disease (CAD)

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Fatih Uzun, Professor; Phone Number: 902126922000; Email: fatihuzun28@gmail.com
• Study Contact Backup: Name: Abdullah Doğan, MD

Study Locations

• Turkey
  • İstanbul, Turkey, 33484
    • Recruiting
    • Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
    • Contact: Ahmet Güner, MD; Phone Number: +905056533335; Email: ahmetguner488@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Complex coronary bifurcation disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Controlled balloon-crush Group
Double kissing-crush stenting Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2025.03-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No