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

NCT06880978 | Recruiting

• 1 other identifier: 2025.02-25
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Coronary bifurcation; death; revascularization; stenting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Major adverse cardiovascular and cerebral events (MACCE)

  12-months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Complex coronary bifurcation disease

You may qualify if:

• Aged \>18
• PCI with mini-crush or controlled balloon-crush
• Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, 33484, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Death; Myocardial Infarction; Stroke

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Fatih Uzun, Professor

CONTACT

+90 5057705766; fatihuzun28@gmail.com

Ahmet Güner, MD

CONTACT

+90 2126922000; ahmetguner488@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 18, 2025
• Study Start: March 3, 2025
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

TU (1)