No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
400 (estimated)
Sponsor
Istanbul Mehmet Akif Ersoy Educational and Training Hospital · Government
Who this trial is looking for
This trial is looking for patients aged over 18 with complex coronary bifurcation lesions. Participants will undergo a procedure using either the mini-crush or controlled balloon-crush technique to treat their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am over 18 years old.
I need a procedure for a complex coronary bifurcation lesion.
You may not be able to join if
I have non-complex bifurcation anatomy.
I have had a heart attack in the past 6 months.
I am in cardiogenic shock.
I have had in-stent restenosis.
I have a history of coronary artery bypass grafting.
I have received a bare-metal stent.
I have end-stage liver or kidney disease.
I have less than 1 year of life expectancy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 compare…
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.
Trial Locations
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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 …
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
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