Comparing mini-crush and controlled balloon-crush techniques for treating coronary bifurcation lesions
Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions
This study is testing whether two different stenting techniques, mini-crush and controlled balloon-crush, work better for treating complex heart artery blockages in people with coronary bifurcation lesions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul Mehmet Akif Ersoy Educational and Training Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06880978 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of two stenting techniques, mini-crush and controlled balloon-crush, in treating complex coronary bifurcation lesions. The mini-crush technique has been widely used by interventional cardiologists, but challenges remain in its execution, particularly in rewiring and balloon advancement. The study aims to compare clinical outcomes between these two techniques to determine if one offers significant advantages over the other. Participants will be monitored for complications such as myocardial infarction and stent thrombosis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with complex coronary bifurcation lesions suitable for PCI using mini-crush or controlled balloon-crush techniques.
Not a fit: Patients with non-complex bifurcation anatomy or those with severe comorbidities such as end-stage liver or kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with complex coronary bifurcation lesions, potentially reducing complications and improving outcomes.
How similar studies have performed: Previous studies have shown comparable outcomes between mini-crush and other stenting techniques, indicating that this approach is not entirely novel but still holds potential for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged \>18 * PCI with mini-crush or controlled balloon-crush * Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1) Exclusion Criteria: * Non-complex bifurcation anatomy * Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush) * ST-elevation myocardial infarction * Cardiogenic shock status * In-stent restenosis * A history of coronary artery bypass grafting * Implantation of bare-metal stent * End-stage hepatic or renal disease * \<1-year life expectancy
Where this trial is running
Istanbul
- Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Fatih Uzun, Professor
- Email: fatihuzun28@gmail.com
- Phone: +90 5057705766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.