A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.

Fundación EPIC501 enrolled

Overview

This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.

This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .

Study Type

OBSERVATIONAL

Enrollment

501

Conditions

Ischemic Heart Disease Coronary Artery Disease

Interventions

TANSEI stentDEVICE

stenting with the TANSEI sirolimus-eluting stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age\> 18 years. * With indication of percutaneous revascularization. * Complex coronary lesion defined as: * Left main lesion AND/OR * Lesion located at a major bifurcation (side branch \>2mm) AND/OR * Lesion located in a small vessel (\<2.5 mm reference diameter by visual estimation) AND/OR * Lesion length \> 35 mm * Informed consent signed. Exclusion Criteria: * Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention). * Life expectancy of the patient under 1 year. * Patients included in other studies or clinical trials. * Clinical decision that excludes the use of drug-eluting stents. * Confirmed allergy to aspirin and / or thienopyridines.

Locations (17)

Hospital Clinico Universitario de Santiago de Compostela

Santiago de Compostela, LA Coruña, Spain

Hospital Universitario de A Coruña

A Coruña, Spain

Outcomes

Primary Outcomes

Safety.The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).

The composite of cardiac death, myocardial infarction (MI) and stent thrombosis (Academic Research Consortium definitive/probable).

Time frame: 12 months

Efficacy.The incidence of clinically driven target lesion revascularization.

The incidence of clinically driven target lesion revascularization (TLR).

Time frame: 12 months

Secondary Outcomes

All death.

Time frame: 12 months

Cardiac death.

Time frame: 12 months

Target Vessel revascularization.

Time frame: 12 months

Target lesion revascularization.

Time frame: 12 months

Stent thrombosis (ARC definite/probable).

Time frame: 12 months

Major bleeding event (BARC type 2-5).

Time frame: 12 months

Stroke.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.