Mini-Crush or Controlled Balloon-Crush for True Coronary Bifurcation Lesions

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06880978

2025.02-25

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Mini-crush stenting Group

Description:

Stenting with mini-crush technique for true coronary bifurcation lesions

Controlled balloon-crush Group

Description:

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