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

Coronary Artery Disease Clinical Trial

— T-REX  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05782738
• Other study ID #: 001-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2029

Study information

• Verified date: April 2023
• Source: San Luigi Gonzaga Hospital
• Contact: Giulio Piedimonte, MD
• Phone: +393201764900
• Email: giulio.piedimonte[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 361
• Est. completion date: June 1, 2029
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Ciriè Hospital	Ciriè	Tori O
Italy	L'Azienda Ospedaliera (AO) S. Croce e Carle	Cuneo
Italy	Ospedale Santa Croce	Moncalieri	Torino
Italy	Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy	Turin

Sponsors (1)

Lead Sponsor	Collaborator
San Luigi Gonzaga Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute closure of the side branch and periprocedural-MI.	The investigators check safety of procedural profile between two techniques.	Periprocedural
Other	Intraprocedural ST and periprocedural-MI	The investigators check safety of procedural profile between two techniques.	Periprocedural
Other	Major bleeding (BARC 3 and 5)	The investigators check safety of hemorrhagic profile between two techniques in consideration of prolonged DAPT.	5-years
Other	Technical success	Defined as TIMI flow 3 and < 30% residual stenosis after PCI on target vessel	Procedural
Other	Procedural success	Defined as technical success with no in-hospital major adverse	Periprocedural
Other	Cross-over between groups	Possibility to switching between two techniques for technical reasons	Periprocedural
Other	Timing of rewiring	Measure of the time spending in a crucial phase of the two techniques	Periprocedural
Other	Number of guide wire used	Number of coronary guidewires to perform the assigned technique.	Periprocedural
Other	Amount of contrast medium used	Total contrast medium used to perform the PCI with the technique assigned	Periprocedural
Other	Procedural time	Total time used to perform the PCI	Periprocedural
Other	Fluoroscopic time	Total fluoroscopic time spending to perform the PCI	Periprocedural
Other	X-rays exposition	Total operators x-rays exposition during the PCI	Periprocedural
Primary	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.	The investigators check eventually differences in technical and clinical performance between the two techniques through coronary angiography or Coro-TC (centre preferences).	12-moths
Secondary	Cardiac death + TVMI + ST	The investigators check mid-term cardiovascular clinical performance between the two techniques.	5-years
Secondary	Cardiac death + TVMI + ST +TLR	The investigators check mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site.	5-years