An observational study in Coronary Bifurcation Lesions, Death and Myocardial Infarction (MI), sponsored by Istanbul Mehmet Akif Ersoy Educational and Training Hospital. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Istanbul Mehmet Akif Ersoy Educational and Training Hospital · Observational
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.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's planned enrollment of 400 is close to the median of 400 across 236 observational studies indexed under Death.
Browse Death studies →Istanbul Mehmet Akif Ersoy Educational and Training Hospital is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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Complex coronary bifurcation disease
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Exclusion Criteria:
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Life expectancy
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Stenting with mini-crush technique for true coronary bifurcation lesions
Stenting with controlled balloon-crush technique for true coronary bifurcation lesions
Major adverse cardiac events (MACE)
The primary endpoint is defined as the composite of the rates of major adverse cardiac events (MACE) (%) including cardiac death (%), target vessel myocardial infarction (%), and target lesion revascularization (%).
Time frame: 12-months
Major adverse cardiovascular and cerebral events (MACCE)
The secondary endpoint (clinical) is defined as the composite of the rates of major adverse cardiac and cerebral events (MACCE) (%) including all-cause death (%), target vessel myocardial infarction (%), target lesion revascularization (%), probable or definite stent thrombosis (%), or stroke (%).
Time frame: 12-months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Aug 2025, 4 months after the start.
Of 84 non-industry observational studies under Death, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 245. This study's planned 4 months is below that.
Counting every sponsor, half of 87 studies reached it within 60 months; a quarter within 23 and three quarters within 245.
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Istanbul Mehmet Akif Ersoy Educational and Training Hospital