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NCT Number: NCT05782738

Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation

The Reverse T-stenting And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation. 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 the Reverse-TAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ciriè Hospital, Cirié, Tori O, Italy

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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 revascularisation (TVR) than 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 in the External Minicrush, 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 Reverse T-stenting, And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation. 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, studies need to compare the Reverse-TAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients >18 years old;
  • Patients with an indication of PCI, including Chronic Coronary syndrome (CCS) and Acute Coronary Syndrome (ACS), according to current guidelines recommendations; According to Medina and Definition criteria, patients with at least true and complex coronary lesions involved in coronary bifurcation.

Exclusion criteria

  • Patients that refused informed consent;
  • Patients without valid vascular access that could make unsafe PCI;
  • Patients with an expected life of less than one year;
  • Patients with scheduled major surgery that required prolonged DAPT interruption;
  • Pregnant patients;
  • Patients with DAPT contraindications.

Treatment and study plan

Percutaneous coronary intervention

Procedure

Use dedicated two stents technique for treatment of coronary bifurcation stenosis

Primary outcomes

  1. Target Lesion Failure (TLF) (Composite of all causes of death, non-fatal TVMI, ischemia-driven target lesion revascularisation (TLR) + Definite or probable ST+ ISR >50% at planned coronary angiography or Coro-TC.

    Time frame: 12-moths

    The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).

Secondary outcomes

  1. Cardiac death + TVMI + ST

    Time frame: 5-years

    The investigators check mid-term cardiovascular clinical performance between the two techniques.

  2. Cardiac death + TVMI + ST +TLR

    Time frame: 5-years

    The investigators check mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site.

Other outcomes

  1. Acute closure of the side branch and periprocedural-MI.

    Time frame: Periprocedural

    The investigators check safety of procedural profile between two techniques.

  2. Intraprocedural ST and periprocedural-MI

    Time frame: Periprocedural

    The investigators check safety of procedural profile between two techniques.

  3. Major bleeding (BARC 3 and 5)

    Time frame: 5-years

    The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT.

  4. Technical success

    Time frame: Procedural

    Defined as TIMI flow 3 and < 30% residual stenosis after PCI on target vessel

  5. Procedural success

    Time frame: Periprocedural

    Defined as technical success with no in-hospital major adverse

  6. Cross-over between groups

    Time frame: Periprocedural

    Possibility to switching between two techniques for technical reasons

  7. Timing of rewiring

    Time frame: Periprocedural

    Measure of the time spending in a crucial phase of the two techniques

  8. Number of guide wire used

    Time frame: Periprocedural

    Number of coronary guidewires to perform the assigned technique.

  9. Amount of contrast medium used

    Time frame: Periprocedural

    Total contrast medium used to perform the PCI with the technique assigned

  10. Procedural time

    Time frame: Periprocedural

    Total time used to perform the PCI

  11. Fluoroscopic time

    Time frame: Periprocedural

    Total fluoroscopic time spending to perform the PCI

  12. X-rays exposition

    Time frame: Periprocedural

    Total operators x-rays exposition during the PCI

Study contacts

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

Enrico Cerrato, MD, phD

CONTACT

[email protected]

Giulio Piedimonte, MD

CONTACT

[email protected]

+393201764900

Sponsors and collaborators

Lead sponsor

San Luigi Gonzaga Hospital

Other

Registry information

Official study title

A Randomized Clinical Study Comparing Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation (T-REX Trial)

Acronym: T-REX

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Mar 24, 2023
Registry last updated
Apr 19, 2023

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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