Coronary Bifurcation LesionsNCT06880978
Mini-Crush Or Controlled Balloon-Crush For True Coronary Bifurcation Lesions
An observational study of Coronary Bifurcation Lesions and Death, run by Istanbul Mehmet Akif Ersoy Educational and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bifurcation Lesions, Death, Myocardial Infarction (MI)
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 1 Aug 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Complex coronary bifurcation disease
Who may be able to join
- Aged >18
- PCI with mini-crush or controlled balloon-crush
- Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)
Who cannot join
- Non-complex bifurcation anatomy
- Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush)
- ST-elevation myocardial infarction
- Cardiogenic shock status
- In-stent restenosis
- A history of coronary artery bypass grafting
Show all 9Show fewer
- Implantation of bare-metal stent
- End-stage hepatic or renal disease
- <1-year life expectancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, 33484
Ahmet Güner, MD, 05056533335, ahmetguner488@gmail.com
Bilal Boztosun, MD
About this study
The mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive cardiologists. Moreover, mini-crush and double kissing-crush techniques have been compared in terms of clinical results in both left main and non-left main coronary bifurcation patient populations and no significant difference was found. However, the most important challenges of the mini-crush technique are the rewiring and advancement of a 1:1 non-compliant side-branch balloon after the main branch stent has been implanted. These challenges usually necessitate the use of a low profile balloon or additional support maneuvers (such as anchor balloon). Recently, a novel modified mini-crush-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon) and this causes less disruption of the stent cells. This prospective observational study aims to assess the procedural and 1-year clinical outcomes of the contemporary mini-crush and controlled balloon-crush (modified mini-crush) double stenting techniques in patients with true coronary bifurcation lesions.
- Keywords
- Coronary bifurcation, death, revascularization, stenting
- Medical subject headings
- Death, Myocardial Infarction, Stroke
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 | Stenting with mini-crush technique for true coronary bifurcation lesions | |
| Controlled balloon-crush Group | Stenting with controlled balloon-crush technique for true coronary bifurcation lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE)
The primary endpoint is defined as the composite of the rates of major adverse cardiac events (MACE) (%) including cardiac death (%), target vessel myocardial infarction (%), and target lesion revascularization (%).
Measured: 12-months
Secondary outcomes (1)
Major adverse cardiovascular and cerebral events (MACCE)
The secondary endpoint (clinical) is defined as the composite of the rates of major adverse cardiac and cerebral events (MACCE) (%) including all-cause death (%), target vessel myocardial infarction (%), target lesion revascularization (%), probable or definite stent thrombosis (%), or stroke (%).
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 posted18 Mar 2025
- Study start3 Mar 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Bifurcation LesionsStudies 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
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
- Sponsor type
- Other government
- Collaborators
- Istanbul Medipol University Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Başakşehir Çam & Sakura City Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Ankara Etlik City Hospital, Ankara City Hospital Bilkent, Istanbul University - Cerrahpasa, Trakya University, Cigli Regional Training Hospital, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital, İstanbul Bağcılar 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
- NCT06880978
- Sponsor's protocol ID
- 2025.02-25
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Controlled Balloon-Crush For True Coronary Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT06880978
- Acronym / sponsor ID
- 2025.02-25
- Keywords
- Coronary bifurcation, death, revascularization, stenting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training HospitalOther government
- Collaborators
- Istanbul Medipol University Hospital, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital, Başakşehir Çam & Sakura City Hospital, Sisli Hamidiye Etfal Training and Research Hospital, Ankara Etlik City Hospital, Ankara City Hospital Bilkent, Istanbul University - Cerrahpasa, Trakya University, Cigli Regional Training Hospital, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital, İstanbul Bağcılar Training and Research Hospital
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 18 Mar 2025 (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 mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive cardiologists. Moreover, mini-crush and double kissing-crush techniques have been compared in terms of clinical results in both left main and non-left main coronary bifurcation patient populations and no significant difference was found. However, the most important challenges of the mini-crush technique are the rewiring and advancement of a 1:1 non-compliant side-branch balloon after the main branch stent has been implanted. These challenges usually necessitate the use of a low profile balloon or additional support maneuvers (such as anchor balloon). Recently, a novel modified mini-crush-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon) and this causes less disruption of the stent cells. This prospective observational study aims to assess the procedural and 1-year clinical outcomes of the contemporary mini-crush and controlled balloon-crush (modified mini-crush) double stenting techniques in patients with true coronary bifurcation lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-crush stenting Group | – | –Stenting with mini-crush technique for true coronary bifurcation lesions |
| Controlled balloon-crush Group | – | –Stenting with controlled balloon-crush technique for true coronary bifurcation lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Complex coronary bifurcation disease
Key inclusion criteria (3 listed)
- Aged >18
- PCI with mini-crush or controlled balloon-crush
- Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)
Key exclusion criteria (9 listed)
- Non-complex bifurcation anatomy
- Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush)
- ST-elevation myocardial infarction
- Cardiogenic shock status
- In-stent restenosis
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 adverse cardiac events (MACE)
Time frame: 12-months
The primary endpoint is defined as the composite of the rates of major adverse cardiac events (MACE) (%) including cardiac death (%), target vessel myocardial infarction (%), and target lesion revascularization (%).
1 secondary outcome
Major adverse cardiovascular and cerebral events (MACCE)
Time frame: 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Bifurcation Lesions
Enrolling by invitationObservational study
Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Progress Bifurcation Global Registry
Coronary Artery Disease, Coronary Bifurcation Lesions
Recruiting
"Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI
Coronary Artery Disease (CAD), Chronic Coronary Syndrome
Active, not recruitingObservational study
Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients
Cardiovascular Disease, Coronary Artery Occlusion
RecruitingObservational study
Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions
Coronary Bifurcation Lesion, Coronary Artery Disease (CAD)
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.
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 Coronary Bifurcation Lesions and Death, 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 9 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatih Uzun, Professor (+90 5057705766, fatihuzun28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac 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?
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.