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

NCT06484647 | Recruiting

• 1 other identifier: 001-2024
• Study Type: observational
• Target: 382
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Ischemic Heart Disease; Chronic Coronary Syndrome; Acute Coronary Syndrome

Keywords

Percutaneous Coronary Intervention (PCI); Coronary Artery Disease (CAD); Coronary Bifurcation Lesion (CBL)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Stent thrombosis (ST)

  5-years

• Intrastent-restenosis (ISR)

  5-years

• Target Vessel MI (TVMI)

  5-years

Study Arms (2)

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

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 * Rewiring * POT * KBI * Final POT technique

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention PROCEDURE

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; T-stenting And Minimal Protrusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Luigi Gonzaga Hospital: lead

Study Sites (1)

Rivoli Hospital

Rivoli, Turin, 10098, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Acute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Giulio Piedimonte, MD

CONTACT

+393201764900; giulio.piedimonte@gmail.com

Enrico Cerrato, MD, PhD

CONTACT

+393479317104; enrico.cerrato@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, MD

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)