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

NCT ID: NCT06546748

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

531 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-22

Study Completion Date

2024-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Left Main Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Mini-crush Stenting Group

No interventions assigned to this group

Double kissing-crush Stenting Group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Koşuyolu Kartal Heart Training and Research Hospital

OTHER

Sponsor Role collaborator

Basaksehir Cam & Sakura City Hospital

UNKNOWN

Sponsor Role collaborator

Medipol University

OTHER

Sponsor Role collaborator

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role collaborator

Bağcılar Training and Research Hospital

UNKNOWN

Sponsor Role collaborator

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role collaborator

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

OTHER

Sponsor Role collaborator

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ahmet Guner

Associate Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmet Güner

Istanbul, Turkey, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 40396672 (View on PubMed)

Other Identifiers

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2024.04-42

Identifier Type: -

Identifier Source: org_study_id

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