Clinical trial NCT05782738: Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Stenosis
Coronary Disease
Keywords: Reverse TAP
External Minicrush
Coronary bifurcation lesion
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 12-moths
Secondary outcomes:
measure: Cardiac death + TVMI + ST
timeFrame: 5-years
measure: Cardiac death + TVMI + ST +TLR
timeFrame: 5-years
Other outcomes:
measure: Acute closure of the side branch and periprocedural-MI.
timeFrame: Periprocedural
measure: Intraprocedural ST and periprocedural-MI
timeFrame: Periprocedural
measure: Major bleeding (BARC 3 and 5)
timeFrame: 5-years
measure: Technical success
timeFrame: Procedural
measure: Procedural success
timeFrame: Periprocedural
measure: Cross-over between groups
timeFrame: Periprocedural
measure: Timing of rewiring
timeFrame: Periprocedural
measure: Number of guide wire used
timeFrame: Periprocedural
measure: Amount of contrast medium used
timeFrame: Periprocedural
measure: Procedural time
timeFrame: Periprocedural
measure: Fluoroscopic time
timeFrame: Periprocedural
measure: X-rays exposition
timeFrame: Periprocedural
Locations:
city: Ciriè
country: Italy
facility: Ciriè Hospital
state: Tori O
city: Moncalieri
country: Italy
facility: Ospedale Santa Croce
state: Torino
city: Alessandria
country: Italy
facility: Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
city: Cuneo
country: Italy
facility: L'Azienda Ospedaliera (AO) S. Croce e Carle
city: Turin
country: Italy
facility: Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy
Study officials:
affiliation: Ospedale degli Infermi di Rivoli (TO)
name: Giulio Piedimonte, MD
role: PRINCIPAL_INVESTIGATOR
References: