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NCT06931574Recruiting

Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions

Comparison of Cardiovascular Outcomes of Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bifurcation Lesions

Source: ClinicalTrials.gov · Last updated 17 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation. The main disadvantage of the historical Crush technique is the low success rate of the final kissing balloon inflation. An improvement came with the introduction of double kissing crush stenting aiming for the shorter protrusion and kissing balloon dilation performed before and after main branch stent implantation. The double kissing crush provides a significant reduction in major adverse cardiovascular events compared to Provisional stenting, Crush, and Culotte techniques. Recently, a novel modified mini-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. To date, no data compares the mid-term outcomes of double kissing crush and controlled balloon-crush stenting techniques in patients with complex coronary bifurcation lesions. Hence, this study aimed to determine the clinical results of double kissing crush and controlled balloon-crush techniques under mid-term follow-up.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
8 Apr 2025
Start date
1 Apr 2025
Primary completion date
1 Nov 2026
Lead sponsor
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
NCT number
NCT06931574

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 1 Apr 2025 to the primary completion date, 1 Nov 2026
  • 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.

Prior treatment

  • A previous of coronary artery bypass grafting

Other illness

  • ST-elevation myocardial infarction
  • End-stage hepatic or renal disease

Other

  • Non-complex bifurcation anatomy
  • Bail-out 2-stent (reverse modified mini-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 either DK-crush or Controlled balloon-crush
  • Complex coronary bifurcation lesion (Medina 0.1.1, 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.