Actively Recruiting
Mini-Crush or Controlled Balloon-Crush Techniques for Treating True Coronary Bifurcation Lesions
Led by Istanbul Mehmet Akif Ersoy Educational and Training Hospital · Updated on 2025-03-18
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Lead Sponsor
I
Istanbul Medipol University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two techniques, the contemporary mini-crush and the controlled balloon-crush (a modified mini-crush), used to treat complex coronary bifurcation lesions. This prospective observational study aims to compare the procedural outcomes and one-year clinical results of these two double stenting methods in patients with true coronary bifurcation lesions. The study focuses on challenges like rewiring and balloon advancement after stenting, which are common in the mini-crush technique. The mini-crush technique is a widely used two-stent method, but it can be difficult to rewire and advance a side-branch balloon after placing the main branch stent. The controlled balloon-crush technique improves this by crushing the side branch stent more gently, allowing easier rewiring and balloon passage. Patients will receive either the traditional mini-crush or the controlled balloon-crush stenting method for their coronary bifurcation lesion. Participants will be monitored for one year, with researchers tracking major adverse cardiac events (MACE) as the main outcome. They will also observe major adverse cardiovascular and cerebral events (MACCE) during this period. The study is observational, so it focuses on following patient outcomes after treatment rather than testing new drugs. The total participation duration is one year following the procedure, during which clinical events and safety outcomes will be recorded.
CONDITIONS
Brief Title
Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Undergoing PCI with mini-crush or controlled balloon-crush stenting
- Presence of complex coronary bifurcation lesion (Medina 0.1.1 or Medina 1.1.1)
You will not qualify if you...
- Non-complex bifurcation anatomy
- Use of bail-out 2-stent techniques (reverse mini-crush or reverse controlled balloon-crush)
- ST-elevation myocardial infarction
- Cardiogenic shock status
- In-stent restenosis
- History of coronary artery bypass grafting
- Implantation of bare-metal stent
- End-stage liver or kidney disease
- 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 - 12 months
Participants who undergo mini-crush or controlled balloon-crush stenting are observed to evaluate major adverse cardiac and cardiovascular events.
Regular follow-up visits during the 12-month period
Trial Site Locations
Total: 1 location
1
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
Ahmet Güner, 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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