Comparing two techniques for treating complex coronary bifurcation lesions
Comparison of Cardiovascular Outcomes of Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bifurcation Lesions
Istanbul Mehmet Akif Ersoy Educational and Training Hospital · NCT06931574
This study is testing two different ways to treat complex heart artery blockages to see which one helps patients feel better and have fewer heart problems after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul Mehmet Akif Ersoy Educational and Training Hospital (other gov) |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT06931574 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two techniques, double kissing-crush and controlled balloon-crush, for treating complex coronary bifurcation lesions in patients undergoing percutaneous coronary intervention (PCI). The double kissing-crush technique aims to improve outcomes by reducing major adverse cardiovascular events compared to traditional methods. The controlled balloon-crush technique is a newer approach that allows for easier rewiring of the side branch, potentially enhancing procedural success. The study will observe patients aged over 18 with specific coronary lesion types to determine which technique yields better results.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with complex coronary bifurcation lesions suitable for PCI using either the double kissing-crush or controlled balloon-crush techniques.
Not a fit: Patients with non-complex bifurcation anatomy or those with severe conditions such as ST-elevation myocardial infarction or end-stage organ disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with complex coronary bifurcation lesions.
How similar studies have performed: Previous studies have shown promising results with the double kissing-crush technique, indicating potential success for this comparative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul and 1 other locations
- Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- 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: 902126922000
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.
Conditions: Coronary Arterial Disease, Percutaneous Coronary Intervention, Bifurcation Coronary Disease