NCT06546748Completed
Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions
Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions: The EVOLUTE-CRUSH Left Main Study
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
The Crush technique has evolved significantly since its introduction to the literature by Colombo et al in 2003, with multiple iterations including mini-crush (MC) and double kissing-crush (DKC) stenting techniques. The main principle of crush techniques for complex bifurcation lesions is to protrude the side branch (SB) stent towards the main branch to adequately cover the SB ostium and minimize the risk of SB ostium restenosis. It was noticed that the 4-5 mm protrusion of the SB stent resulted in a large volume of the crushed stent and the technique was modified into MC which aimed for approximately 1-2 mm protrusion by Galassi et al in 2007. Despite all the disadvantages of the crush technique, the final kissing balloon inflation (KBI) rate of this technique, along with several iterations has been up to 98%. Moreover, a recent meta-analysis showed that MC was associated with a reduction in risk of major cardiovascular events compared to provisional stenting, crush, and culotte techniques. The DKC is a planned 2-stent technique introduced by Chen et al. The ultimate innovation of this approach is that it is designed to increase the success rate of the final KBI. Provided recrossing of the crushed stent occurs through the proximal cell: another advantage of the DKC technique is to improve the success of KBI. The DKC significantly reduced major cardiovascular events (MACE) compared to provisional stenting, crush, TAP, and culotte. Until now, no clinical investigation has compared the DKC and MC in patients with complex left main bifurcation lesions. Therefore, this study sought to determine the clinical results of DKC and MC stenting techniques under long-term follow-up.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 531 (actual)
- First submitted
- 6 Aug 2024
- Start date
- 22 Jul 2024
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06546748
What you commit to
- Study type: Observational
- Participants enrolled: 531
- From 22 Jul 2024 to the primary completion date, 30 Oct 2024
- 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
- prior history of coronary artery bypass grafting
- inappropriate dual antiplatelet therapy
- treated with a bare metal stent
Other illness
- end-stage liver or kidney disease
- allergy to antiplatelet therapy or contrast media
- PCI for ST-segment elevation myocardial infarction or in-stent restenosis
Other
- cardiogenic shock
- critically ill with \< 1-year life expectancy
- absence of all medical records
- non-complex bifurcation lesions
Who the study is looking for
- true complex left main bifurcation lesions
- stenting with double kissing-crush or mini-crush as a 2-stent strategy
- participation in regular clinical follow-up
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ahmet Güner Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.