e-NOBORI Observational Registry of Nobori DES
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01261273
- Lead Sponsor
- Terumo Europe N.V.
- Brief 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18000
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FREEDOM OF TARGET LESION FAILURE 1 YEAR TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION
- Secondary Outcome Measures
Name Time Method Cardiac death/ Myocardial Infarction 1 AND 2 YEARS Cardiac death/ Myocardial Infarction
Clinically driven target vessel revascularization (TVR) 1 AND 2 YEARS PCI AND CABG
Clinically driven target lesion revascularization (TLR) 1 & 2 YEARS re-PCI or CABG involving target lesion
Peri-procedural myocardial infarction 1 MONTH Peri-procedural myocardial infarction
Acute/subacute stent thrombosis 1 MONTH (definite/probable according to ARC definitions)
Device success 1 MONTH Device Success defined as attainment of a final residual diameter stenosis of the target lesion of \< 30% by visual assessment and/or \< 50% by QCA, using the assigned device only.
Device Success defined as attainment of a final residual diameter stenosis of the target lesion of \< 30% by visual assessment and/or \< 50% by QCA, using the assigned device only.
Device success is defined as attainment of a final residual diameter stenosis of the target lesión of \<30% by visual assessment and/or \>50% QCA, using the assigned device only.Major vascular and bleeding complications 1 MONTH NOT CABG RELATED
Stent thrombosis 1 month, 1 and 2 years post-procedure definite and probable according to ARC definitions
Clinically driven Target Lesion Revascularization 1 MONTH Clinically driven Target Lesion Revascularization
Procedural success 1 MONTH Procedural success is defined as achievement of a diameter of stenosis of \<30% by visual assessment and/or \<50% by QCA, using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesión during the hospital stay.
Rate of Major Adverse Cardiac Events (MACE) 1 MONTH Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR)
Composite Endpoint of Cardiac death and MI 1 MONTH, 1 AND 2 YEARS Composite Endpoint of Cardiac death and MI
Primary Stent thrombosis 1 month, 1 and 2 years post-procedure definite and probable according to ARC definitions
Composite Endpoint of Cardiac death, post-procedural MI and stent thrombosis rate during the course of DAT versus the same events after cessation of DAT UP TO 2 YEARS Composite Endpoint of Cardiac death, post-procedural MI and stent thrombosis rate during the course of DAT versus the same events after cessation of DAT
Target Lesion Failure (TLF) 1 MONTH AND 2 YEARS Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization
Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR 1 MONTH, 1 AND 2 YEARS Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR
Composite Endpoint of Cardiac death and post-procedural MI 1 month, 1 and 2 years post-procedure Composite Endpoint of Cardiac death and post-procedural MI
Duration of dual antiplatelet therapy UP TO 2 YEARS Duration of dual antiplatelet therapy
Secondary Stent thrombosis 1 month, 1 and 2 years post-procedure definite and probable according to ARC definitions
Clinically driven Target Vessel Revascularization 1 MONTH Clinically driven Target Vessel Revascularization
Trial Locations
- Locations (257)
SMZ-Donauspital Vienna
🇦🇹Vienna, Austria
National Heart Foundation Hospital & Research Institute
🇧🇩Dhaka, Bangladesh
Republican Clinical Medical Center (Presidential Hospital)
🇧🇾Minsk, Belarus
Republican Scientific and Practical Center of Cardiology
🇧🇾Minsk, Belarus
Mogilev Regional Clinical Hospital
🇧🇾Mogilev, Belarus
Hospital Madre Teresa
🇧🇷Belo Horizonte, Brazil
Hospital Santa Isabel-Sociedade Divina Providência
🇧🇷Blumenau, Brazil
HMCP PUC-Campinas
🇧🇷Campinas, Brazil
Hospital E Maternidade Madre Teodora
🇧🇷Campinas, Brazil
Hospital Vera Cruz Campinas
🇧🇷Campinas, Brazil
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