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NCT06880978Recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
11 Mar 2025
Start date
3 Mar 2025
Primary completion date
1 Aug 2025
Lead sponsor
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
NCT number
NCT06880978

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From 3 Mar 2025 to the primary completion date, 1 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • ST-elevation myocardial infarction
  • A history of coronary artery bypass grafting
  • End-stage hepatic or renal disease

Other

  • Non-complex bifurcation anatomy
  • Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush)
  • Cardiogenic shock status
  • In-stent restenosis
  • Implantation of bare-metal stent
  • \<1-year life expectancy

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.