Actively Recruiting
Comparison of Cardiovascular Outcomes of Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bifurcation Lesions
Led by Istanbul Mehmet Akif Ersoy Educational and Training Hospital · Updated on 2025-04-17
300
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
I
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Lead Sponsor
S
Sisli Hamidiye Etfal Training and Research Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two stenting techniques, double kissing crush and controlled balloon-crush, for treating complex coronary bifurcation lesions in patients with coronary arterial disease. This observational study aims to compare the mid-term clinical outcomes of these two methods, as the controlled balloon-crush technique is a newer approach designed to improve side branch access and reduce stent disruption. The study is sponsored by Istanbul Mehmet Akif Ersoy Educational and Training Hospital and focuses on complex cases classified by the Medina system. Participants will have undergone percutaneous coronary intervention (PCI) using either the double kissing crush or the controlled balloon-crush technique. The controlled balloon-crush method involves a more controlled crushing of the side branch stent to allow easier rewiring and balloon passage. No additional interventions or treatments are described, as this is an observational study comparing the outcomes of these two stenting techniques. Throughout the study, researchers will monitor participants for 36 months to measure the primary endpoint of target lesion failure. Data collection will include clinical follow-up to assess cardiovascular outcomes after the stenting procedure. Participants' health status will be tracked over this period to evaluate the safety and effectiveness of the techniques under real-world conditions.
CONDITIONS
Brief Title
Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged >18
- Underwent PCI with either double kissing crush or controlled balloon-crush technique
- Have a complex coronary bifurcation lesion classified as Medina 0.1.1 or Medina 1.1.1
You will not qualify if you...
- Have non-complex bifurcation anatomy
- Underwent bail-out 2-stent (reverse modified mini-crush)
- Experienced ST-elevation myocardial infarction
- Are in cardiogenic shock status
- Have in-stent restenosis
- Had previous coronary artery bypass grafting
- Received implantation of bare-metal stent
- Have end-stage hepatic or renal disease
- Have life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 months
Participants who underwent PCI with either double kissing crush or controlled balloon-crush techniques are observed for cardiovascular outcomes.
Periodic visits for follow-up assessments
Trial Site Locations
Total: 2 locations
1
Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye), 33484
Actively Recruiting
2
Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye), 33484
Actively Recruiting
Research Team
F
Fatih Uzun, Professor
A
Abdullah Doğan, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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