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Enrolling by invitationNCT07849335Updated Sep 30, 2026

Minicrush Versus Culotte Stenting in Complex Coronary Bifurcation Lesions:The Multicenter T-REX II Registry

An observational study in Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI) and Bifurcation Coronary Artery Disease, sponsored by San Luigi Gonzaga Hospital. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by San Luigi Gonzaga Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Coronary Artery Disease (CAD)
  • Percutaneous Coronary Intervention (PCI)
  • Bifurcation Coronary Artery Disease

Keywords

  • Minicrush
  • Culotte
  • PCI
  • Bifurcation lesions
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • Patients with complex coronary bifurcation lesions according to DEFINITION criteria

Exclusion criteria

Exclusion Criteria:

  • \<18 years
  • Treatment with other techniques
  • Non-complex coronary bifurcation lesions
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Minicrush Patients

    Culotte Patients

    Procedure: Percutaneous Coronary Intervention with Minicrush

Interventions

  • ProcedurePercutaneous Coronary Intervention with Minicrush

    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.

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What researchers measure

Primary outcomes

  1. Target Lesion Failure (TLF)

    Composite of cardiac death, Target Vessel Myocardial Infarction and Target Lesion Revascularization

    Time frame: 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

    Time frame: From the enrollment to the endif the treatment at 5 years

06

Study locations

1 site
  • Rivoli Hospital
    Rivoli, Turin 10098, Italy
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be available for sharing to protect participant privacy and compliance with informed consent limitations.

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07849335
Lead sponsor
San Luigi Gonzaga Hospital
Responsible party
Enrico Cerrato (MedicalDoctor, San Luigi Gonzaga Hospital) — Principal investigator
First posted
Sep 30, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Sep 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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