NCT01261273

e-NOBORI Observational Registry of Nobori DES

Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18,000 (actual)
• Sponsor: Terumo Europe N.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

* Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients. * 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 * Clinical Site Locations: 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 * Patient is more or equal 18 years old; * Patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and RVD matches available Nobori® DES sizes); * Patient has been informed of the nature of the study and agrees to its provisions, has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists. 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 * Insulin Dependent Diabetes Mellitus (IDDM) * Non-Insulin Dependent Diabetes Mellitus (NIDDM) * 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)

Conditions

• Coronary Artery Disease

Timeline

• Start date: 2010-08-25
• Primary completion: 2016-05-01
• Completion: 2016-05-27
• First posted: 2010-12-16
• Last updated: 2019-10-09

Locations

257 sites across 32 countries: Austria, Bangladesh, Belarus, Brazil, Bulgaria, Chile, Czechia, Denmark, Egypt, Estonia, France, Georgia, Germany, Hungary, Indonesia, Ireland, Israel, Latvia, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Russia, Serbia, Slovenia, Spain, Sweden, Taiwan, Ukraine, United Kingdom