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Not yet recruiting NCT05782738

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

No phase Interventional Coronary Artery Disease Coronary Stenosis Coronary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous Coronary Intervention.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Coronary Stenosis, Coronary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Percutaneous Coronary Intervention
    Use dedicated two stents technique for treatment of coronary bifurcation stenosis

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Cardiac death + TVMI + ST [Time frame: 5-years]
  • Cardiac death + TVMI + ST +TLR [Time frame: 5-years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 5 centers
  • Ciriè Hospital — Cirié
  • Ospedale Santa Croce — Moncalieri
  • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo — Alessandria
  • L'Azienda Ospedaliera (AO) S. Croce e Carle — Cuneo
  • Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital — Turin

Identifiers

NCT: NCT05782738 · 001-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗