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NCT Number: NCT06484647

Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation

Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

  • According to DEFINITION criteria, PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization (TVR) compared to Provisional Stenting
  • The Double-Kissing Crush stenting (DK-Crush) has been tested with the Culotte and the Classic Crush techniques in the unprotected left main disease (ULMD) and in no-ULMD setting, respectively, showing better clinical outcomes.
  • However, due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush, it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation
  • The DK-Crush technique has never been tested with the External Minicrush, leaving the operators to choose one or the other according to their experience and preferences.
  • The T-stenting And Minimal Protrusion (TAP) is a two-stent technique described to treat coronary bifurcation after provisional treating. Compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting.
  • Nowadays, no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.
  • The issue's importance is highlighted by higher rates of stent thrombosis (ST) and in-stent restenosis (ISR) of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8.
  • Consequently, investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients >18 years of age
  • Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina)
  • Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1

Exclusion criteria

  • Patients who do not want or cannot sign the informed consent for the procedure.
  • Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe.
  • Patients with a life expectancy of <1 year.
  • Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy.
  • Pregnant women.
  • Patients who cannot take antiplatelet therapy for any reason.

Treatment and study plan

Percutaneous coronary intervention

Procedure

Percutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation.

The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique.

Primary outcomes

  1. Target Lesion Failure (TLF)

    Time frame: 5-years

    a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)

Secondary outcomes

  1. Stent thrombosis (ST)

    Time frame: 5-years

    Thrombosis of the stent after PCI

  2. Intrastent-restenosis (ISR)

    Time frame: 5-years

    Intrastent restenosis with >50% of the stent diameter

  3. Target Vessel MI (TVMI)

    Time frame: 5-years

    Target vessel myocardial infarction at follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Enrico Cerrato, MD, PhD

CONTACT

[email protected]

+393479317104

Giulio Piedimonte, MD

CONTACT

[email protected]

+393201764900

Sponsors and collaborators

Lead sponsor

San Luigi Gonzaga Hospital

Other

Registry information

Official study title

Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation: Insights From TREX Registry

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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