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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Coronary Disease; Coronary Stenosis
• Interventions: Procedure: Percutaneous Coronary Intervention

• Registration Number: NCT05782738
• Lead Sponsor: San Luigi Gonzaga Hospital

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.

Study Timeline

• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-03-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-19
• Study Start: 2023-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 361

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reverse TAP	Percutaneous Coronary Intervention	-
External Minicrush	Percutaneous Coronary Intervention	-

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
Cardiac death + TVMI + ST	5-years	The investigators check mid-term cardiovascular clinical performance between the two techniques.
Cardiac death + TVMI + ST +TLR	5-years	The investigators check mid-term cardiovascular clinical performance between the two techniques, including any revascularization of the target lesion site.

Trial Locations

Locations (5)

Ciriè Hospital; 🇮🇹 Ciriè, Tori O, Italy

Ospedale Santa Croce; 🇮🇹 Moncalieri, Torino, Italy

L'Azienda Ospedaliera (AO) S. Croce e Carle; 🇮🇹 Cuneo, Italy

Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy; 🇮🇹 Turin, Italy