NCT06880978 Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions
| NCT ID | NCT06880978 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul Mehmet Akif Ersoy Educational and Training Hospital |
| Condition | Coronary Bifurcation Lesions |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2025-08-01 |
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 400 participants in total. It began in 2025-03-03 with a primary completion date of 2025-08-01.
⚠ 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 mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive cardiologists. Moreover, mini-crush and double kissing-crush techniques have been compared in terms of clinical results in both left main and non-left main coronary bifurcation patient populations and no significant difference was found. However, the most important challenges of the mini-crush technique are the rewiring and advancement of a 1:1 non-compliant side-branch balloon after the main branch stent has been implanted. These challenges usually necessitate the use of a low profile balloon or additional support maneuvers (such as anchor balloon). Recently, a novel modified mini-crush-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. This prospective observational study aims to assess the procedural and 1-year clinical outcomes of the contemporary mini-crush and controlled balloon-crush (modified mini-crush) double stenting techniques in patients with true coronary bifurcation lesions.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06880978 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Bifurcation Lesions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06880978 currently recruiting?
Yes, NCT06880978 is actively recruiting participants. Contact the research team at fatihuzun28@gmail.com for enrollment information.
Where is the NCT06880978 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06880978 clinical trial?
NCT06880978 is sponsored by Istanbul Mehmet Akif Ersoy Educational and Training Hospital. The trial plans to enroll 400 participants.