Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients
Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients
Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.
Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.
Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year
Up to 200 centres across Europe, Asia and Central and South America
-Patient Population : ~18000 eligible patients suitable for treatment with the Nobori® DES will be entered in the e-NOBORI registry
Eligibility Criteria
NOTE: In order to avoid bias it is recommended that all investigators aim to enrol all consecutive patients complying with study eligibility criteria. It is also desirable to have at least two cardiologists as investigators in each centre.
According to pre-specified criteria, patients will be automatically allocated to one or more sub-studies as following:
NOBORI Acute Coronary Syndrome
NOBORI Stable angina
NOBORI Female
NOBORI Bifurcation
NOBORI Diabetes
NOBORI Small Vessels (less or equal 2.75mm)
NOBORI Long Lesions (more or equal 20mm)
NOBORI Renal Insufficiency (> 2.0 mg/dL - 176 µmol/mL)
NOBORI Elderly (more or equal 80 years of age)
NOBORI Restenosis
NOBORI Multivessel Treatment
NOBORI Complex Lesions
In addition to above mentioned sub-studies there will be geographic sub-studies for the main areas.
Medication Pre-Procedure: According to hospital routine practice Post-Procedure: Mandatory antiplatelet treatment, according to hospital routine practice (minimum 6 months DAT)
Inclusion Criteria:
Exclusion Criteria:
Riga, Latvia
León, Guanajuato, Mexico
Merida, Yucatan, Mexico
Monterrey, Nuevo León, Mexico
San Luis Potosi SLP, Mexico
s'Hertogenbosch, Netherlands
Novosibirsk, 630055, Russia
Bilbao- Vizcaya, Spain
Bizkaia, Spain
Majadahonda-Madrid, Spain
Taichung R.o.c., Taiwan
District of North East Lincolnshire, United Kingdom
Dorset, United Kingdom
North Manchester, United Kingdom
Surrey, United Kingdom