Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-03

Study Completion Date

2026-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Bifurcation Lesions Death Myocardial Infarction (MI) Stent Thrombosis Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mini-crush stenting Group

Stenting with mini-crush technique for true coronary bifurcation lesions

No interventions assigned to this group

Controlled balloon-crush Group

Stenting with controlled balloon-crush technique for true coronary bifurcation lesions

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No