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

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.

Study Overview

• Status: Completed
• Conditions: Left Main Coronary Artery Disease

• Study Type: Observational
• Enrollment (Actual): 531

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 33484
    • Ahmet Güner

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

This multicenter observational study was retrospectively conducted between January 2014 and January 2024, and patients who underwent percutaneous coronary intervention (PCI) for complex left main coronary bifurcation lesions.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• prior history of coronary artery bypass grafting
• cardiogenic shock
• end-stage liver or kidney disease
• allergy to antiplatelet therapy or contrast media
• inappropriate dual antiplatelet therapy
• critically ill with < 1-year life expectancy
• absence of all medical records
• PCI for ST-segment elevation myocardial infarction or in-stent restenosis
• non-complex bifurcation lesions
• treated with a bare metal stent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mini-crush Stenting Group
Double kissing-crush Stenting Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiovascular events (MACE)	Cardiac death, clinically-driven target lesion revascularization, target vessel myocardial infarction	12 months

Collaborators and Investigators

• Sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
• Collaborators: Sisli Hamidiye Etfal Training and Research Hospital; Medipol University; Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital; Ankara Etlik City Hospital; Koşuyolu Kartal Heart Training and Research Hospital; Başakşehir Çam & Sakura City Hospital; Bağcılar Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2024.04-42

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