NCT06931574 Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions
| NCT ID | NCT06931574 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul Mehmet Akif Ersoy Educational and Training Hospital |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-04-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06931574 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06931574 currently recruiting?
Yes, NCT06931574 is actively recruiting participants. Contact the research team at fatihuzun28@gmail.com for enrollment information.
Where is the NCT06931574 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06931574 clinical trial?
NCT06931574 is sponsored by Istanbul Mehmet Akif Ersoy Educational and Training Hospital. The trial plans to enroll 300 participants.