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

Comparing T-stenting And Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation: Insights From TREX Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Ischemic Heart Disease; Chronic Coronary Syndrome
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention

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 Type: Observational
• Enrollment (Estimated): 382

Contacts and Locations

• Study Contact: Name: Giulio Piedimonte, MD; Phone Number: +393201764900; Email: giulio.piedimonte@gmail.com
• Study Contact Backup: Name: Enrico Cerrato, MD, PhD; Phone Number: +393479317104; Email: enrico.cerrato@gmail.com

Study Locations

• Italy
  • Turin
    • Rivoli, Turin, Italy, 10098
      • Recruiting
      • Rivoli Hospital
      • Contact: Giulio Piedimonte, MD; Phone Number: +393201764900; Email: giulio.piedimonte@gmail.com
      • Contact: Enrico enrico.cerrato@gmail.com, MD; Phone Number: +393479317104; Email: enrico.cerrato@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

ACS or CCS patients with complex coronary bifurcation lesions with the indication of PCI.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T-stenting And Minimal Protrusion; 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	Procedure: Percutaneous Coronary Intervention; Percutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation. The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique.
External Minicrush; 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; RewiringPOTKBIFinal POT technique	Procedure: Percutaneous Coronary Intervention; Percutaneous coronary intervention is a procedure that require coronary stenosis dilatation with dilatation catheter balloon and generally stent implantation. The study involve coronary stenosis at bifurcation level that require complex coronary techniques such as External Minicrush or TAP technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	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)	5-years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: San Luigi Gonzaga Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention (PCI); Coronary Artery Disease (CAD); Coronary Bifurcation Lesion (CBL)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 001-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No