Coronary Artery Disease (CAD)NCT07849335
Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry
An observational study of Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial summary
Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy. While the double kissing crush technique has been extensively studied, limited contemporary data are available comparing alternative two-stent approaches, particularly Minicrush and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention with Minicrush
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 1 Apr 2027
- How long will I take part?
- 5 Years
- 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: This cohort study included all patients with complex coronary bifurcation lesions who received intentional two-stent treatment with the Minicrush or Culotte techniques
Who may be able to join
- Patients with complex coronary bifurcation lesions according to DEFINITION criteria
Who cannot join
- <18 years
- Treatment with other techniques
- Non-complex coronary bifurcation lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy. While the double kissing crush technique has been extensively studied, limited contemporary data are available comparing alternative two-stent approaches, particularly Minicrush and T-stenting and Culotte, in complex bifurcation anatomy. This study aimed to compare procedural characteristics and long-term clinical outcomes of Minicrush versus Culotte stenting techniques in patients undergoing PCI for complex coronary bifurcation lesions.
- Conditions
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention with Minicrush
- Keywords
- Minicrush, Culotte, PCI, Bifurcation lesions
- 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.
Percutaneous Coronary Intervention with MinicrushProcedure or surgery
The Minicrush and Culotte techniques were performed as upfront two-stent strategies according to standard protocols focusing on minimal side-branch stent protrusion and carina reconstruction, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Minicrush Patients | Culotte Patients Receives: Procedure: Percutaneous Coronary Intervention with Minicrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
Composite of cardiac death, Target Vessel Myocardial Infarction and Target Lesion Revascularization
Measured: From the enrollment to the end of the study at 5 years
Secondary outcomes (1)
Major Adverse Cardiovascular Events (MACE)
Composite of all-cause of death, Target vessel Myocardial Infarction and Target Vessel Revascularization
Measured: From the enrollment to the endif the treatment at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Cerrato, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849335
- Sponsor's protocol ID
- 007/2026
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available for sharing to protect participant privacy and compliance with informed consent limitations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry
- ClinicalTrials.gov ID
- NCT07849335
- Acronym / sponsor ID
- 007/2026
- Conditions
- Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Artery Disease
- Keywords
- Minicrush, Culotte, PCI, Bifurcation lesions
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 30 Sep 2026 (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.
Percutaneous coronary intervention (PCI) of complex coronary bifurcation lesions frequently requires an upfront two-stent strategy. While the double kissing crush technique has been extensively studied, limited contemporary data are available comparing alternative two-stent approaches, particularly Minicrush and T-stenting and Culotte, in complex bifurcation anatomy. This study aimed to compare procedural characteristics and long-term clinical outcomes of Minicrush versus Culotte stenting techniques in patients undergoing PCI for complex coronary bifurcation lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minicrush Patients | – | Procedure: Percutaneous Coronary Intervention with MinicrushCulotte Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort study included all patients with complex coronary bifurcation lesions who received intentional two-stent treatment with the Minicrush or Culotte techniques
Key inclusion criteria (1 listed)
- Patients with complex coronary bifurcation lesions according to DEFINITION criteria
Key exclusion criteria (3 listed)
- <18 years
- Treatment with other techniques
- Non-complex coronary bifurcation lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary Intervention with MinicrushThe Minicrush and Culotte techniques were performed as upfront two-stent strategies according to standard protocols focusing on minimal side-branch stent protrusion and carina reconstruction, respectively. | Procedure or surgery | Minicrush Patients |
Primary outcome
Target Lesion Failure (TLF)
Time frame: From the enrollment to the end of the study at 5 years
Composite of cardiac death, Target Vessel Myocardial Infarction and Target Lesion Revascularization
1 secondary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: From the enrollment to the endif the treatment at 5 years
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 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available for sharing to protect participant privacy and compliance with informed consent limitations.
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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.
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 Coronary Artery Disease (CAD) and Percutaneous Coronary Intervention (PCI), run by San Luigi Gonzaga Hospital at 1 site in Italy.
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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 30 Sep 2026. 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 Italy. 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?
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?
Target Lesion Failure (TLF) (time frame: From the enrollment to the end of the study at 5 years). 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 30 Sep 2026.