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

Last updated: April 14, 2023
Sponsor: San Luigi Gonzaga Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cardiovascular Disease

Vascular Diseases

Chest Pain

Treatment

N/A

Clinical Study ID

NCT05782738
001-2023
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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.

Study Design

Total Participants: 361
Study Start date:
June 01, 2023
Estimated Completion Date:
June 01, 2029

Study 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.

Connect with a study center

  • Ciriè Hospital

    Ciriè, Tori O 10073
    Italy

    Site Not Available

  • Ospedale Santa Croce

    Moncalieri, Torino 10024
    Italy

    Site Not Available

  • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121
    Italy

    Site Not Available

  • L'Azienda Ospedaliera (AO) S. Croce e Carle

    Cuneo, 12100
    Italy

    Site Not Available

  • Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy

    Turin, 10100
    Italy

    Site Not Available

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