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Clinical Trials/NCT06546748
NCT06546748CompletedNot Applicable

Mini Crush or Double Kissing Crush Stenting Techniques for Complex Left Main Bifurcation Lesions: the EVOLUTE-CRUSH Left Main Study

Istanbul Mehmet Akif Ersoy Educational and Training Hospital1 site in 1 country531 target enrollmentStarted: July 22, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
531
Locations
1
Primary Endpoint
Major cardiovascular events (MACE)

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Major cardiovascular events (MACE)

Time Frame: 12 months

Cardiac death, clinically-driven target lesion revascularization, target vessel myocardial infarction

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Ahmet Guner

Associate Professor of Cardiology

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Study Sites (1)

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