Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions

NCT06546748 | Completed

• 1 other identifier: 2024.04-42
• Study Type: observational
• Target: 531
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Main Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major cardiovascular events (MACE)

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

  12 months

Study Arms (2)

Mini-crush Stenting Group

Double kissing-crush Stenting Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Mehmet Akif Ersoy Educational and Training Hospital: lead
• Koşuyolu Kartal Heart Training and Research Hospital: collaborator
• Basaksehir Cam & Sakura City Hospital: collaborator
• Medipol University: collaborator
• Sisli Hamidiye Etfal Training and Research Hospital: collaborator
• Bağcılar Training and Research Hospital: collaborator
• Ankara Etlik City Hospital: collaborator
• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: collaborator

Study Sites (1)

Ahmet Güner

Istanbul, Turkey, 33484, Turkey (Türkiye)

Location

Related Publications (1)

• Uzun F, Guner A, Hakgor A, Alizade E, Karatas MB, Alici G, Cizgici AY, Sahin I, Gul I, Pusuroglu H, Karaduman A, Akman C, Atas AE, Deniz MF, Tekin DN, Serin E, Kocaaga M, Yasan M, Avci II, Senoz O, Varim P, Dogan A, Dursun A, Unkun T, Cetin I, Gokalp M, Tanik VO, Aktuk IF, Cakal B, Keskin K, Guner EG, Simsek A, Ekiz MA, Uzel ST, Bulus C, Ciloglu K, Goksu MM, Calik AN, Boztosun B. DK-Crush or Mini-Crush Stenting for Complex Left Main Bifurcation Lesions: The Multicenter EVOLUTE-CRUSH LM Registry. J Am Heart Assoc. 2025 Jun 17;14(12):e040166. doi: 10.1161/JAHA.124.040166. Epub 2025 May 21.

  PMID: 40396672 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: July 22, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

TU (1)