Left Main Coronary Artery DiseaseNCT06546748
Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions
An observational study of Left Main Coronary Artery Disease, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Main Coronary Artery Disease
- How many people
- 531 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2024to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Left Main Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mini-crush Stenting Group | Not described | |
| Double kissing-crush Stenting Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major cardiovascular events (MACE)
Cardiac death, clinically-driven target lesion revascularization, target vessel myocardial infarction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start22 Jul 2024
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Main Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Sponsor type
- Other government
- Collaborators
- Koşuyolu Kartal Heart Training and Research Hospital, Başakşehir Çam & Sakura City Hospital, Medipol University, Sisli Hamidiye Etfal Training and Research Hospital, Bağcılar Training and Research Hospital, Ankara Etlik City Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Responsible party
- Principal investigator, Ahmet Guner, Istanbul Mehmet Akif Ersoy Educational and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546748
- Sponsor's protocol ID
- 2024.04-42
- Status last verified
- Mar 2025
- First submitted
- 6 Aug 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40396672
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Crush or Double Kissing Crush Stenting Techniques For Complex Left Main Bifurcation Lesions: The EVOLUTE-CRUSH Left Main Study
- ClinicalTrials.gov ID
- NCT06546748
- Acronym / sponsor ID
- 2024.04-42
- Conditions
- Left Main Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training HospitalOther government
- Collaborators
- Koşuyolu Kartal Heart Training and Research Hospital, Başakşehir Çam & Sakura City Hospital, Medipol University, Sisli Hamidiye Etfal Training and Research Hospital, Bağcılar Training and Research Hospital, Ankara Etlik City Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-crush Stenting Group | – | – |
| Double kissing-crush Stenting Group | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major cardiovascular events (MACE)
Time frame: 12 months
Cardiac death, clinically-driven target lesion revascularization, target vessel myocardial infarction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 40396672Uzun 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Main Coronary Artery Disease, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major cardiovascular events (MACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.