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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Ahmet Güner, MD; Phone Number: +90 2126922000; Email: ahmetguner488@gmail.com
• Study Contact Backup: Name: Fatih Uzun, Professor; Phone Number: +90 5057705766; Email: fatihuzun28@gmail.com

Study Locations

• Turkey
  • İstanbul, Turkey, 33484
    • Recruiting
    • Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
    • Contact: Ahmet Güner, MD; Phone Number: 05056533335; Email: ahmetguner488@gmail.com
    • Contact: Bilal Boztosun, MD
    • Contact: Aykun Hakgör, MD
    • Contact: Ali Nazmi Çalık, MD
    • Contact: Mehmet Baran Karataş, MD
    • Contact: Hamdi Püşüroğlu, MD
    • Contact: İrfan Şahin, MD
    • Contact: Murat Gök, MD
    • Contact: Veysel Ozan Tanık, MD
    • Contact: Gökhan Çiçek, MD
    • Contact: Hasan Ali Barman, MD
    • Contact: Kudret Keskin, MD
    • Contact: İlker Gül, MD
    • Contact: İbrahim Faruk Aktürk, MD
    • Contact: Ahmet Arif Yalçın, MD
    • Contact: Fatih Uzun, MD
    • Contact: Ahmet Karaduman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Complex coronary bifurcation disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mini-crush stenting Group; Stenting with mini-crush technique for true coronary bifurcation lesions
Controlled balloon-crush Group; Stenting with controlled balloon-crush technique for true coronary bifurcation lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	12-months

Collaborators and Investigators

• Sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
• Collaborators: Sisli Hamidiye Etfal Training and Research Hospital; Ankara City Hospital Bilkent; Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital; Istanbul Medipol University Hospital; Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital; Trakya University; Cigli Regional Training Hospital; Ankara Etlik City Hospital; İstanbul Bağcılar Training and Research Hospital; Başakşehir Çam & Sakura City Hospital; Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: stenting; revascularization; death; Coronary bifurcation
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Embolism and Thrombosis; Myocardial Ischemia; Ischemia; Thrombosis; Myocardial Infarction; Infarction
• Other Study ID Numbers: 2025.02-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No