Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation

Recruiting

• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Acute Coronary Syndrome; Chronic Coronary Syndrome
• Interventions: Procedure: Percutaneous Coronary Intervention

• Registration Number: NCT06484647
• Lead Sponsor: San Luigi Gonzaga Hospital

Brief Summary

Nowadays, no studies compare the T-stenting And Minimal Protrusion (TAP) and External Minicrush techniques in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

Detailed Description

1. According to DEFINITION criteria, PCI of the complex coronary bifurcation with up-front two stent techniques is associated with lower target vessel revascularization (TVR) compared to Provisional Stenting

2. 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.

3. However, due to its technical complexity and simultaneous improvement of the Classic Crush technique evolving in the External Minicrush, it has meant that the latter has become the most used technique in the clinical practice in treating complex coronary bifurcation

4. 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.

5. The T-stenting And Minimal Protrusion (TAP) is a two-stent technique described to treat coronary bifurcation after provisional treating. 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.

6. Nowadays, no studies compare theTAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

7. The issue's importance is highlighted by higher rates of stent thrombosis (ST) and in-stent restenosis (ISR) of the two stent techniques compared to Provisional Stenting in treating coronary bifurcation8.

8. Consequently, investigating the efficacy and safety differences between the techniques could improve the treatment of complex coronary bifurcation to reduce post-PCI TLR.

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Status Verified: 2024-07
• Study First Posted: 2024-07-03
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-08-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 382

Inclusion Criteria

• Patients >18 years of age
• Patients with an indication for PCI, including chronic coronary syndrome and acute coronary syndromes (STEMI, NSTEMI, unstable angina)
• Patients with at least one true coronary bifurcation according to the Medina classification 1.1.1, 0.1.1, 1.0.1, 0.0.1

Exclusion Criteria

• Patients who do not want or cannot sign the informed consent for the procedure.
• Patients with severe peripheral vascular disease that limits vascular access to the point of making the procedure unsafe.
• Patients with a life expectancy of <1 year.
• Patients with planned major surgery require prolonged discontinuation of antiplatelet therapy.
• Pregnant women.
• Patients who cannot take antiplatelet therapy for any reason.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T-stenting And Minimal Protrusion	Percutaneous Coronary Intervention	Percutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC). The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath. Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily). The procedural steps of the technique are described below: * MV stenting * Distal rewiring towards SB * Kissing Balloon for opening distal struts towards SB * SB stent implantation * Final Kissing Balloon
External Minicrush	Percutaneous Coronary Intervention	Percutaneous coronary intervention is performing according to current coronary Revascularization guidelines (ACC/ESC). The vascular access is chosing according patients characteristics and operator preferences and require radial or femoral insertion of the sheath. Antiplatelets strategy is a discretion of the operator and is depending on clinical presentation of the patients and respect the current guidelines (i.e Clopidogrel 600 mg load dose following 75 mg/daily, Ticagrelor 180 mg load dose following 180 mg/daily, Prasugrel 60 mg load dose following 10 mg/daily). The procedural steps of the technique are described below: * SB stent deployment with protrusion into MB * Crush the SB stent with a balloon inflating into MB (\>0.5 mm of the SB stent) * MB stent deployment * Rewiring * POT * KBI * Final POT technique

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	5-years	a composite of cardiac death and target vessel-related myocardial infarction (TV-MI), including Q wave, non-Q wave myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Target Vessel MI (TVMI)	5-years	Target vessel myocardial infarction at follow-up
Intrastent-restenosis (ISR)	5-years	Intrastent restenosis with \>50% of the stent diameter
Stent thrombosis (ST)	5-years	Thrombosis of the stent after PCI

Trial Locations

Locations (1)

Rivoli Hospital; 🇮🇹 Rivoli, Turin, Italy